AI on the HSA register

MRI Image Analysis software is a software solution intended to be used for viewing, manipulation, communication, and storage of Brain(T1WI), Cardiac(CINE, T1 Mapping, LGE, T2W, Perfusion), Prostate (T2WI, DWI, ADC) and Liver (T1WI and contrast enhanced T1WI, T2WI, DWI, ADC) MRI images. It supports interpretation and evaluation of examinations within healthcare institutions.

HSA registration MDPR260518E0001 · filed by Shanghai United Imaging Intelligence Co., Ltd.

An AI-based software that analyzes knee X-ray images to output the Kellgren-Lawrence (K-L) grade (≤1,2,3,4) and the predicted Grading Prediction Score for each grade for both knees. It automatically annotates the joint line, joint space narrowing, and osteophytes with contours or lines to support physicians in diagnosing osteoarthritis

HSA registration MDPR260428G0003 · filed by CONNECTEVE Co., Ltd.

V5med Lung AI is a Computer-Aided Detection (CAD) software designed to assist radiologists in detecting pulmonary nodules (with diameter of 4-30 mm) during CT examinations of the chest for asymptomatic populations aged 18 years and older. This software provides adjunctive information to alert radiologists to regions of interest with suspected lung nodules that may otherwise be overlooked. It can be used in a concurrent read mode, where the AI analysis results are displayed alongside the original CT images during either the initial review or any subsequent reviews by the radiologist. While it serves as a valuable adjunct tool, V5med Lung AI does not replace the radiologist’s critical judgment or diagnostic processes and should not be used in isolation from the original CT series.

HSA registration MDPR260424I0009 · filed by V5med Inc.

HAI-RadX Suite CT Chest is a medical device intended to assist clinicians with the interpretation of radiological imaging studies and provide notification of suspected findings.

HSA registration MDPR260422Z0002 · filed by Harrison-AI Medical Pty Ltd

EIRL Chest Screening is a software program package that analyzes chest X-ray images acquired by an X-ray diagnostic device and provides processed image information to assist in medical image diagnosis. EIRL Chest Screening is consisting of the following software: - EIRL Chest Metry (supports measurement in chest X-ray images) - EIRL Chest XR (supports detection of potential abnormal areas in chest X-ray images)

HSA registration MDPR260324D0005 · filed by LPIXEL Inc.

The Genius™ Digital Diagnostics System, when used with the Genius™ Cervical AI algorithm, is a qualitative, in vitro diagnostic device indicated for assisting in cervical cancer screening of ThinPrep® Pap test slides, for the presence of atypical cells, cervical neoplasia, including its precursor lesions (Low Grade Squamous Intraepithelial Lesions, High Grade Squamous Intraepithelial Lesions), and carcinoma, as well as all other cytological categories, including adenocarcinoma, as defined by The Bethesda System for Reporting Cervical Cytology. The Genius Digital Diagnostics System can also be used with ThinPrep® non-gynecological microscope slides and ThinPrep® UroCyte® microscope slides as an aid to the pathologist to review and interpret digital images.

HSA registration MDPR260312E0009 · filed by Hologic Inc

DeepTek CXR Analyzer is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies using machine learning techniques to identify, categorize, and highlight suspicious ROls in one of the following categories: Lungs, Pleura, Cardiac, and Hardware. The device is intended for use as a concurrent reading aid for radiologists. DeepTek CXR Analyzer v1.0 is indicated for adults and transitional adolescents (18 to <22 years old but treated like adults) only.

HSA registration MDPR260306A0002 · filed by Deep Tek Medical Imaging Private Limited

ClariPulmo is a non-invasive medical image analysis software for use with CT images, intended to aid the assessment of lung lesions (e.g., emphysema, pneumonia, lung nodules, and other pulmonary abnormalities) and to support the physician in confirming the presence or absence, characterization, and quantification of physician-identified lung lesions. The software provides automated segmentation of the lungs and quantitative analysis of low-attenuation and high-attenuation lung areas using predefined Hounsfield unit (HU) thresholds. It supports automated detection, segmentation, and volumetric measurement of lung nodules in screening and follow-up examinations, including longitudinal tracking and calculation of Volume Doubling Time (VDT) for growth assessment. The software also provides estimation of nodule malignancy based on a predefined formula that is clinically accepted and publicly available. ClariPulmo displays the segmented lungs and identified lesions using color overlays to assist visualization and interpretation. Optional deep learning-based denoising and kernel normalization functions are provided to improve detection and quantification performance in cases where CT images are acquired under low-dose conditions or reconstructed with sharp kernels. In addition, the software supports automated segmentation and quantification of anatomical organs included in the input CT images and enables presentation of quantified values in user-defined units based on predefined HU thresholds and conversion tables.

HSA registration MDPR260301U0001 · filed by ClariPi Inc.

ClariCT.AI is a DICOM-native medical imaging software intended for denoise processing and enhancement of CT DICOM images when higher image quality and/or lower dose acquisitions are desired. The software provides noise reduction and image enhancement functions to support improved visualization of medical images. The ClariACE Module is an optional module that improves the contrast-to-noise ratio (CNR) of contrast-enhanced CT (CECT) images through advanced contrast enhancement functionality. The ClariPET-CT Module is an optional module that performs denoise processing and enhancement of PET-CT fusion images expressed in 16-bit DICOM secondary capture format, supporting noise reduction particularly in low-dose PET imaging.

HSA registration MDPR260228C0001 · filed by ClariPi Inc.

Augmento is a web-based PACS and radiology workflow management solution. It receives digital images and data from various DICOM compliant sources (i.e. CT scanners, MR scanners, ultrasound systems, RF Units, PET Units, computed & digital radiographic devices, secondary capture devices, imaging gateways and other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and/or across computer networks at distributed locations. Only preprocessed DICOM 'for presentation' images can be interpreted for primary image diagnosis in mammography. Lossy compressed images and digitized film screens of mammographic images must not be reviewed for primary image interpretations. This system is meant to be used by trained and qualified medical professionals, e.g physicians, radiologists, nurses, and medical technicians.

HSA registration MDPR260107Y0001 · filed by DeepTek Medical Imaging Private Limited

The CystoSmart System is a computer-assisted reading tool designed to aid endoscopists (using cystoscopes) in detecting bladder lesions and tumors by processing of images obtained during standard white-light cystoscopy examinations of patients undergoing screening and surveillance endoscopic bladder evaluations. This device is not intended to replace clinical decision making.

HSA registration MDPR251219E0003 · filed by Claritas HealthTech Pte Ltd

QAi Lymph Node Dx is medical device software intended to assist pathologists in detecting lymph node metastasis associated with cases of breast adenocarcinoma, colon adenocarcinoma, and gastric adenocarcinoma. It is designed for use with lymph node tissues obtained from patients suspected of having breast, colon, or gastric cancers. The software is intended to be operated by trained and qualified pathologists, either remotely or within the setting of a pathology laboratory. It is contraindicated for use with pathology images of insufficient quality and by users lacking necessary training and expertise in pathological analysis. The software produces slide level classification that aid pathologists in detecting lymph node metastasis on Hematoxylin and Eosin (H&E)-stained Whole-Slide Images (WSI) as inputs. It is designed as a clinical decision support system rather than a standalone diagnostic tool.

HSA registration MDPR251126D0005 · filed by Qritive Pte. Ltd.

Annalise Container is a medical device intended to assist clinicians with the interpretation of radiological imaging studies and provide notification of suspected findings. Annalise Containter identifies suspected findings in: - Digitised (CR) or digital (DX) chest X-ray studies taken in the anterior-posterior (AP) or posterior-anterior (PA) and optionallu lateral (LAT) orientations of patients. - Non-contrast brain CT scans (brain kernel) of adult patients.

HSA registration MDPR251124Y0002 · filed by Annalise-AI Pty Ltd

OncoStudio provides deep-learning-based automatic contouring to organs at risk in DICOM-RT format from CT images. This software could be used as an initial contouring for the clinicians to be confirmed by the radiation oncology department for treatment planning or other professions where a segmented mask of organs is needed. • Deep learning contouring from Head & Neck, Thorax, Abdomen, and Pelvis • Generates DICOM-RT structure of contoured objects • Manual Contouring • Receive, transmit, store, retrieve, display, and process medical images and DICOM objects

HSA registration MDPR251027Z0001 · filed by Oncosoft Inc.

Align X-ray Insights is a computer aided detection ('CADe”) software product that aids dental practitioners in the detection and analysis of dental radiographic image data for dental conditions for permanent dentition. The product is used in a professional dental practice environment by dental practitioners. Align X-ray Insights analyzes bitewing, periapical, and panoramic radiographs using a set of artificial intelligence (AI)-based algorithms to assist in the detection of suspected radiographic abnormalities (caries, periapical radiolucencies, periodontal bone loss, and dental calculus), and other radiographic findings (dental fillings, dental crowns, dental implants, dental bridges, root-canal fillings, proximity of lower molars to mandibular canal, and impacted teeth). The classification and segmentation of teeth is used for tooth charting and reporting. The results of Align X-ray Insights are intended to be used in conjunction with evaluation of other patients and clinical information including examination of radiographs as determined by the dentist’s clinical standard of care and should not be solely relied upon to make or confirm a diagnosis.

HSA registration MDPR251001X0007 · filed by Align Technology, Inc.

Chest CT Computer Aided Diagnostic Software (uAI-Discover-Chest) is a software product intended to be used for assisting radiologists in reading, analyzing and interpreting chest CT images of adult patients. It provides tools to detect and analyze suspicious lesions. This software is not intended to be used for providing diagnostic conclusions. Radiologists shall review and evaluate the detection and analysis results provided by the software before reaching diagnostic conclusions. The product consists of three applications, CT Lung Nodule Analysis, CT Pneumonia Analysis and CT Rib Fracture Detection.

HSA registration MDPR250924E0001 · filed by Shanghai United Imaging Intelligence Co., Ltd.

Annalise Container is a medical device intended to assist clinicians with the interpretation of radiological imaging studies and provide notification of suspected findings. Annalise container identifies suspected findings in: • Digitised (CR) or digital (DX) chest X-ray studies taken in the anterior-posterior (AP) or posterior-anterior (PA) and optionally lateral (LAT) orientations of patients (16years or older).

HSA registration MDPR250826F0001 · filed by Annalise-AI Pty Ltd

InferOperate Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning for patients, including 3D anatomical visualization which provides information for both preoperative surgical planning and intraoperative image display. It is not intended for use with or for the primary diagnostic interpretation of Mammography images.

HSA registration MDPR250814C0001 · filed by Infervision Medical Technology Co., Ltd.

RhoTM is an opportunistic screening tool that analyzes frontal radiographs of the lumbar spine, thoracic spine, chest, pelvis, knee, or hand performed for any clinical indication in patients aged 50 years and older. The algorithm was developed using machine learning to generate a risk score that correlates with a patient's likelihood of having low bone mineral density.

HSA registration MDPR250715C0001 · filed by 16 Bit Inc.

VeriOsteo OP is a locked-algorithm, AI-assisted standalone medical device software used in identifying patients with suspected abnormal bone mineral density (saBMD). Healthcare providers must first verify that the chest PA view X-ray image contains the last thoracic vertebra and first lumbar vertebra before the analysis. Relevant output results cannot serve as the sole basis for clinical diagnosis and cannot substitute a physician’s diagnosis. VeriOsteo OP is intended for chest X-ray images of individuals aged 50 years and above. Output results of the screening is binary and provide only a recommendation that an image either has suspected abnormalities or has not been found to have significant abnormalities.

HSA registration DE0510952 · filed by Acer Medical Incorporated

The Heuron NI a standalone medical device software. It visualizes the nigrosome region in a brain 3D MR image using a learned artificial intelligence (AI)-based algorithm. It provides medical professionals with quantified information such as the volume and z-score of the nigrosome region. Medical professionals can observe the quantified information in detail by adjusting the measurement reference value of the nigrosome region.

HSA registration DE0510919 · filed by Heuron

QAi Prostate Grade is an AI-based software intended for use as an aid during prostate core needle biopsy interpretation in histopathology. The device uses AI algorithms to analyze digitized Hematoxylin and Eosin stained prostate core needle biopsy whole slide image in parallel to ongoing standard of care image interpretation and provides information about the presence of suspected tumor. The user is presented with slide level classification indicating presence of tumor, Gleason score, ISUP grade, digitally calculated metrics and annotations on the WSI. The device is designed to be used as a clinical decision support system, rather than a standalone diagnostic tool. QAi Prostate Grade is intended to be operated by trained and qualified pathologists, either remotely or within the setting of a pathology laboratory. It is contraindicated for use with pathology images of insufficient quality for diagnosis and users lacking necessary training and expertise in pathological analysis.

HSA registration DE0510918 · filed by Qritive Pte. Ltd.

The aiTriage v2 software is intended to provide support to the physician in the evaluation the patient during chest pain triage. The software analyzes simultaneous ECG and will calculate heart rate variability features and output a MACE risk stratification score (0-100). The software also detects the presence of AFib and normal sinus rhythm from the ECG signal. The software does not identify other arrhythmias. aiTriage v2 is not intended as a sole means of diagnosis. aiTriage v2 is only indicated for use on patients 21 years or older, who may be presenting with non-traumatic chest pain.

HSA registration DE0510876 · filed by TIIM Healthcare Pte. Ltd.

The software consists of automated computer-assisted reading tools based on an artificial intelligence(AI) algorithm intended to aid healthcare professionals in detecting multiple findings and related diseases on chest radiograph.

HSA registration DE0510724 · filed by VUNO Inc.

Contour+ (MVision AI Segmentation) provides a software interface to image analysis algorithms to be used in clinical workflows including, but not limited to, radiation therapy treatment planning workflows. The system includes processing tools for automatically contouring of imaging data of supported modalities CT and MRI using machine learning based algorithms. The produced segmentation templates for regions of interest are intended to be transferred to appropriate image visualization systems to be used as a template for a medical professional to visualize, modify and approve prior to further use in clinical workflows. The system supports automatic contouring of pre-defined structures from common anatomical sites, i.e. Head and Neck, Brain, Breast, Lung and Abdomen, Male Pelvis, and Female Pelvis. Contour+ (MVision AI Segmentation) is not intended to detect lesions or tumors. The device is not intended for use with real-time adaptive planning workflows.

HSA registration DE0510627 · filed by MVision AI Oy

iota iScreen Intracranial Haemorrhages (ICH) AI Model is a radiological computer aided triage indicated for use in the analysis of head non-contrast CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging suspected positive findings of pathologies in head non-contrast CT images for ICH. iota iScreen ICH AI Model uses an artificial intelligence algorithm to analyse images and highlight cases with detected ICH in parallel to the current standard of care for image interpretation. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of iota iScreen ICH AI Model are intended to be used in conjunction with other patient information and based on professional judgment, to assist with triage of medical images.

HSA registration DE0510602 · filed by iota medtech Pte Ltd

Neurophet SCALE PET is software for the registration, fusion, display and analysis of medical images from multiple modalities including MRI, CT and PET. The software aids clinician in the assessment and quantification of pathologies from PET scans of the human brain. It enables automatic analysis and visualization of brain PET through the calculation of standard uptake volume ratios (SUVR) and its derived quantitative values within target regions of interest and comparison to those within the reference regions. The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with radio-tracer and disease combinations. This system is a diagnostic aid to assist physicians with analyzing the patient’s brain images and diagnose degenerative brain diseases including Alzheimer’s disease and mild cognitive impairment.

HSA registration DE0510480 · filed by NEUROPHET, Inc.

CT Computer-Aided Triage Software is a radiological computer-assisted triage and notification software device indicated for analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing studies with suspected positive findings of Intracranial Hemorrhage (ICH).

HSA registration DE0510392 · filed by Shanghai United Imaging Intelligence Co., Ltd.

MPXA-2000 is software intended to be used for performing calculations in X-ray angiographic images of the coronary arteries. These calculations are based on vessel contours which are automatically detected by the software and subsequently presented for review and manual editing. The analysis results obtained with MPXA-2000 are intended for use by cardiologists and radiologists: - to support clinical decisions concerning the coronary arteries. - to support the evaluation of intervention or drug therapy applied for conditions of the coronary arteries

HSA registration DE0510331 · filed by Medipixel, Inc.

This device is a diagnostic aid software to assist medical professionals in diagnosing neurodegenerative Parkinson’s disease by analyzing nigrosome 1 MR images and clinical information of neurodegenerative Parkinson’s disease patients and normal people taken through nigrosome 1 imaging protocol.

HSA registration DE0510319 · filed by Heuron

DeepTek CXR Detect is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies using deep learning algorithms to identify, categorize, and highlight suspicious ROIs in one of the following findings: Opacity, Tuberculosis, Pulmonary Nodules, Fibrosis, Lung Mass, Pneumonia, Atelectasis, Pleural Effusion, Pleural Thickening, Pneumothorax, Foreign bodies, Cardiomegaly, and Rib and clavicular fractures. The device is intended for use as a concurrent reading aid for physicians. DeepTek CXR Detect is indicated for X-rays of patients aged 12 and above.

HSA registration DE0510110 · filed by DeepTek Medical Imaging Private Limited

RBfracture is a computer-assisted detection and diagnosis software device to assist healthcare professionals in reviewing trauma skeletal radiographs. The expected clinical benefit of RBfracture is to reduce the number of missed fractures impacting the health of individuals.

HSA registration DE0509747 · filed by Radiobotics ApS

BoneView is a software-only device designed to assist clinicians in the interpretation of X-ray radiographs. BoneView is a software as a service that primarily takes as an input X-ray radiographs in DICOM format, processes them using artificial intelligence (deep learning), and provides as an output the detection of anomalies and/or the determination of the bone age and/or the measurements value of different angles/length for different anatomical areas.

HSA registration DE0509583 · filed by Gleamer SAS

ChestView is a software using deep learning techniques intended to provide preliminary data for helping clinicians’ diagnosis of X-ray radiographs. ChestView is a software-only device designed to assist clinicians in the interpretation of X-ray radiographs. ChestView is a software as a service that primarily takes as an input X-ray radiographs in DICOM format, processes them using artificial intelligence (deep learning), and provides as an output the detection of anomalies and/or the measurements of different length.

HSA registration DE0509568 · filed by Gleamer SAS

The Retinal Image Intelligent Analysis Software is intended for use by health care providers to automatically detect more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy.

HSA registration DE0509557 · filed by Shanghai Airdoc Medical Technology Co., Ltd

Inspectra CXR is an AI-based software that analyzes adult frontal chest x-rays for signs of abnormalities in order to prioritize them for clinical review. Inspectra CXR identifies features suggestive of 8 abnormality conditions: 1.Pleural effusion 2.Tuberculosis 3.Lung opacity 4.Pulmonary edema 5.Mass 6.Nodule 7.Cardiomegaly 8.Atelectasis Inspectra CXR aids radiologists or trained clinicians in the analysis of adult frontal chest x-rays by providing notifications for worklist prioritization and triage. It identifies cases with suspected findings and provides a structured report and secondary capture image through PACS or MyInspectra web application. The device operates in parallel to and independent of standard of care image interpretation workflow. The device is intended as a notification-only tool and does not intend to replace the review of qualified physicians. Its results are not intended to be used to confirm clinical diagnosis or rule out possibility of specific diagnosis.

HSA registration DE0509231 · filed by Perceptra Co., Ltd.

EFAI CARDIOSUITE SPECT MYOCARDIAL PERFUSION AGILE WORKFLOWS is an image processing software that provides analysis on DICOM images acquired from GE Medical Systems Nuclear Quantitative Perfusion SPECT software to support appropriately trained healthcare professionals in the evaluation and assessment of myocardial perfusions. It provides the following functionality: Segmentation of the Bull’s Eye images from the original DICOM; Analysis of the Bull’s Eye images to help assess perfusion; Custom settings to generate text reports. The results of this processing may be used to aid in evaluating and assessing myocardial perfusions. The system is an adjunct tool for GE Medical Systems Nuclear Quantitative Perfusion SPECT software.

HSA registration DE0509187 · filed by Ever Fortune.Al Co., Ltd.

+GCAM is a software product intended as a decision-making aid in the screening fundus images for probable Glaucoma and Age-related Macular Degeneration. The software will provide a suspect/non-suspect recommendation based on the signs detected. The screening result is not intended to be a confirmatory diagnosis or to be definitive in nature. +GCAM is to be used in conjunction with a patient management system for the acquisition of data and display of results. +GCAM is indicated for use by healthcare providers to provide a referral recommendation for glaucoma and AMD based on the features in the colour fundus image.

HSA registration DE0509057 · filed by TELEMEDC PTE LTD

Qritive Prostate SCR AI v1.0 is a pathology machine learning based software intended for use as an aid during prostate core needle biopsy interpretation to detect prostatic adenocarcinoma on Whole Slide Image (WSI). The device uses Artificial Intelligence (AI) algorithms to analyse digitised Haematoxylin and Eosin (H&E) stained prostate core needle biopsy images in parallel to the ongoing standard of care image interpretation and provides information about the presence of suspected tumour. The user is presented with preview images on top of the original image highlighting the suspected tumour that are meant for informational purposes only and not intended for diagnostic use. Qritive Prostate SCR AI v1.0 users are restricted to pathologists. However, the final interpretation needs to be rendered by a certified pathologist. The software is intended to be deployed either on-site or as a remote cloud application.

HSA registration DE0509046 · filed by Qritive Pte. Ltd.

The gastroAI-model G system analyzes gastric endoscopic images acquired by observers for the purpose of disease differentiation of lesions suspected of epithelial tumors (adenomas and adenocarcinoma) arising from the gastric mucosa, and identifies neoplastic lesions based on the visual characteristics of the lesions. The positioning of this system is to assist observers in distinguishing between tumor and nontumor diseases. The gastroAI-model G is intended to detect neoplastic lesions indicated for Endoscopic Submuscosal Dissection (ESD), and the disease states are Gastric Cancer (Type 0-I, 0-IIa, 0-IIb and 0-IIc) and Gastric Adenoma. The gastroAI-model G system is not intended to identify neoplastic lesions not indicated for ESD, specific or special lesions such as raspberry like glandular epithelium type gastric cancer and non- neoplastic lesions. It is not intended to make a definitive diagnosis based solely on the analysis results of this system.

HSA registration DE0508971 · filed by AI Medical Service Inc.

Critical Care Suite is a suite of AI algorithms for the automated image analysis of frontal chest X-rays acquired on a digital x-ray system for the presence of critical findings, quality checks and/or measurements. When Critical Care Suite includes the Pneumothorax algorithm, it produces an onscreen notification, image overlay, and an image flag to enable case prioritization and diagnosis of critical findings (pneumothorax). This information is also transmitted to the radiologist for review When Critical Care Suite includes the Endotracheal Tube algorithm, it produces an on-screen image overlay that detects and localizes an endotracheal tube, locates the endotracheal tube tip, locates the carina, and automatically calculates the vertical distance between the endotracheal tube tip and carina. This information is also transmitted to the radiologist for review.

HSA registration DE0508921 · filed by GE Medical Systems LLC

An image analysis software developed for the quantitative analysis of Coronary Computed Tomography Angiography. Utilizes image processing and artificial intelligence techniques to calculate non-invasive fractional flow reserve (FFR) index, an index quantifying the severity of myocardial ischemia associated with artery stenosis. The purpose is to predict and provide additional information for use in physiological functional assessment of coronary artery disease. To be used as an aid in diagnosis of patients whose health situation is not critical. The predicted results serve only as an assistive tool and must not be taken as the final judgement or conclusion. To be used by trained clinicians together with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgments. Indicated for use as a non-invasive supporting tool to calculate FFR index, suitable for vessel with 30%~90% stenosis based on CTA examination.

HSA registration DE0508732 · filed by Keya Medical Technology Co., Ltd.

See-Mode Augmented Reporting Tool (SMART) is a stand-alone, reporting software for analysis, measurement, and reporting of ultrasound images. The software analyses ultrasound images and extracts specific information from them, such as annotations, measurements, and pathology presented in the image. The software generates a report based on the image analysis results to be reviewed and approved by a qualified clinician after performing quality control. See-Mode Augmented Reporting Tool is intended to be used for patients aged 18 and above.

HSA registration DE0508691 · filed by See-Mode Technologies Pty Ltd

Genius AI Detection software is a computer-aided detection and diagnosis (CADe/CADx) software device intended to be used with compatible digital breast tomosynthesis (DBT) systems to identify and mark regions of interest including soft tissue densities (masses, architectural distortions, and asymmetries) and calcifications in DBT exams from compatible DBT systems and provide confidence scores that offer assessment for Certainty of Findings and a Case Score. The device intends to aid in the interpretation of digital breast tomosynthesis exams in a concurrent fashion, where the interpreting physician confirms or dismisses the findings during the reading of the exam.

HSA registration DE0508688 · filed by Hologic Inc.

The NaviCam Small Bowel Capsule Endoscopy System is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel. The ProScan feature of the ESView software is an optional computer-assisted reading tool designed to aid capsule endoscopy reviewers in identifying images suspected of containing lesions. This feature is not intended to detect pathology in lieu of a physician and should not be used as a substitute for reviewing the entire capsule endoscopy video. This device is not meant to replace upper and/or lower endoscopy procedures

HSA registration DE0508416 · filed by Ankon Technologies Co. Ltd.,

Annalise Enterprise is a medical device intended to assist clinicians with the interpretation of radiological imaging studies and provide notification of suspected findings. Annalise Enterprise identifies suspected findings in: • non-contrast brain CT scans (brain kernel) of adult patients For CT Brain (CTB), the device improves the detection of radiological findings visible on non-contrast CT brain scans.

HSA registration DE0508329 · filed by Annalise-AI Pty Ltd

Koios DS is an artificial intelligence (AI)/machine learning (ML)-based computer-aided diagnosis (CADx) software device intended for use as an adjunct to diagnostic ultrasound examinations of lesions or nodules suspicious for breast or thyroid cancer. Koios DS allows the user to select or confirm regions of interest (ROIs) within an image representing a single lesion or nodule to be analyzed. The software then automatically characterizes the selected image data to generate an AI/ML-derived cancer risk assessment and selects applicable lexicon-based descriptors designed to improve overall diagnostic accuracy as well as reduce interpreting physician variability. Koios DS may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report.

HSA registration DE0508147 · filed by Koios Medical, Inc.

SwiftMR is a stand-alone software solution intended to be used for acceptance, enhancement and transfer of all body parts MR images in DICOM format. It can be used for noise reduction and increasing image sharpness for MR images. SwiftMR is not intended for use on mobile devices.

HSA registration DE0508105 · filed by AIRS Medical Inc.

SenseCare-Chest DR Pro is compliant with DICOM 3.0 standards, using deep learning technology to identify imaging abnormalities of pneumonia, tuberculosis, pneumothorax, pleural effusion, cardiomegaly, and rib fracture and provides quantification analysis results for adults only. This product is only used for assisted diagnosis, cannot be used alone for diagnosis. The final diagnosis result should be given by a qualified professional.

HSA registration DE0508036 · filed by SenseCare Smart Health Technology Co., Ltd.

Neurophet AQUA automatically analyze brain images acquired from magnetic resonance imaging (MRI) devices to reconstruct three-dimensional models and quantitatively display the degree of atrophy of the brain by measuring the volume of each cerebral substructure. The software is indicated for use in individuals who are cognitively normal, with or suspected with MCI (mild cognitive impairment), with or suspected with Alzheimer’s disease.

HSA registration DE0507934 · filed by NEUROPHET, Inc.

qXR is a radiology computer aided analysis software intended for use as an aid during chest X-ray interpretation. The device uses artificial intelligence algorithms to analyze chest Xray images in parallel to the ongoing standard of care image interpretation and provides a list of suspected findings on the chest X-ray. As an added feature, the device is able to identify the location of the suspected abnormalities on the chest X-ray. The user is presented with preview images highlighting the abnormal findings, that are meant for informational purposes only and not intended for diagnostic use.

HSA registration DE0507698 · filed by Qure.AI Technologies Private Limited

AVIEW software is used to store, transfer and display output results by inquiring and analyzing medical images with segmentation and quantification functions. It provides to the physician quantitatively in the diagnosis, evaluation, and documentation by providing image segmentation of sub-structures. This software must be used by a medical expert (e.g., physician, radiologist) who is very aware of the anatomic structures of a patient.

HSA registration DE0507590 · filed by Coreline Soft Co., Ltd.

Neurophet SCALE PET is a software for the registration, fusion, display and analysis of medical images from multiple modalities including MRI and PET. The software aids clinician in the assessment and quantification of pathologies from PET Amyloid/FDG scans of the human brain. It enables automatic analysis and visualization of amyloid protein concentration through the calculation of standard uptake volume ratios (SUVR) within target regions of interest and comparison to those within the reference regions. The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with radio- tracer and disease combinations. The device should only be used as an adjunct tool and not a sole determinant for diagnosis of MCI (mild cognitive impairment) and Alzheimer’s disease only.

HSA registration DE0507567 · filed by NEUROPHET, Inc.

aiTriage™ is intended to capture, analyze and report the MACE score (0-100) and category (low, medium, and high risk) of the patient for chest pain triage. While the aiTriage software is connected to the PMD-250 device, patient vital sign signals are transmitted to the aiTriage software in real-time for continuous recording. After vital sign recording, the signals are analyzed, and a final report is generated based on the HRV information calculated from the entire ECG recording and the patient’s HEAR score input. The system is indicated for use on patients 21 years or older, who may be presenting with non-traumatic chest pain, and have normal sinus rhythm.

HSA registration DE0507506 · filed by TIIM Healthcare Pte. Ltd.

Annalise Enterprise is a medical device intended to assist clinicians with the interpretation of radiological imaging studies and provide notification of suspected findings. Annalise Enterprise identifies suspected findings in digitised (CR) or digital (DX) chest X-ray studies taken in the anterior-posterior (AP) or posterior-anterior (PA) and optionally lateral (LAT) orientations of adult patients The device improves the detection of radiological findings visible on chest X-rays. The device is used on a PC workstation in conjunction with a medical imaging viewer (i.e. PACS system). The device may also be configured to provide input to worklist software to assist with notification and triaging. The device identifies studies with selected findings and communicates these studies to the worklist software which enables triaging of the worklist and notification.

HSA registration DE0507316 · filed by Annalise-AI Pty Ltd

The software automatically analyzes the image of fundus and provides findings with a region of interest(ROI) . Determining 12 findings that can be a disease as below; a. hemorrhage b. hard exudate c. cotton wool patch d. drusen e. membrane f. macular hole g. myelinated nerve fiber h. chorioretinal atrophy i. vascular abnormality j. retinal nerve fiber layer defect k. glaucomatous disc change l. non-glaucomatous disc change - Intended user: Trained Ophthalmologist and healthcare professionals

HSA registration DE0507303 · filed by VUNO Inc.

FxMammo is a radiological computer-assisted detection and diagnostic software intended to aid in the detection of breast cancer on acquired mammography images. The software detects and identifies suspicious breast cancer cases based on features or information extracted from the images. FxMammo is intended as an adjunct tool for physicians.

HSA registration DE0507149 · filed by FathomX Pte Ltd

EM2Clinic is a Software as a Service (SaaS) that has a web platform for supporting dental diagnosis and treatment plan which includes Artificial intelligence (AI) method to identify and annotate both pathological and non-pathological features in dental images. The device is also used to generate automated dental charting based on the AI result and treatment plan recommendation.

HSA registration DE0507137 · filed by EM2Ai Pte. Ltd.

Us2.v2 software is used to process acquired transthoracic cardiac ultrasound images, to analyse and make measurements on images in order to provide automated estimation of several cardiac structural and functional parameters; specifically left/ right atrial and ventricular linear dimensions, volumes, systolic function and diastolic function, measured by B mode, M mode and Doppler (PW, CW, tissue) modalities. The data produced by this software is intended to be used to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners for clinical decision-making. Us2.v2 is indicated for use in adult patients.

HSA registration DE0506894 · filed by Eko.ai Pte. Ltd

The MaxFOV 2 reconstruction software is intended for head and whole body CT scans. The deep learning based Max Field of View (MaxFOV 2) is a CT image reconstruction method intended to produce images of the head and whole-body using Axial, Helical, and Cine acquisitions. MaxFOV 2 is designed to extend the nominal display field of view (DFOV) for cases where patient size and positioning requirements result in a portion of the patient's body to be outside of the nominal DFOV. These extended FOV images are intended for use in radiation therapy planning and are clinically useful for the simulation and planning of radiation therapy for the treatment of cancer for patients. They can also be used for visualization of patient anatomy for cases not involving therapy planning. MaxFOV 2 is intended for patients of all ages, especially bariatric patients.

HSA registration DE0506641 · filed by GE Hangwei Medical Systems Co., Ltd.

SenseCare-Lung Pro is intended for pulmonary nodules and pneumonia (including COVID-19 pneumonia) detection and analysis of chest CT images which is compliant with DICOM 3.0 standards. SenseCare-Lung Pro use deep learning technology to identify imaging abnormalities. It is only used for auxiliary diagnosis and cannot be used to provide diagnosis results.

HSA registration DE0506606 · filed by SenseCare Smart Health Technology Co., Ltd.

The ScreenPoint Transpara® system is intended for use as a concurrent reading aid for radiologists during interpretation of 2D and 3D mammograms of asymptomatic women to identify regions suspicious for breast cancer. Output of the device contains region-based scores indicating the likelihood that cancer is present in specific regions and an overall score indicating the likelihood that cancer is present on the mammogram. Patient management decisions should not be made solely on the basis of analysis by Transpara®.

HSA registration DE0506597 · filed by ScreenPoint Medical B.V.

It is a software based on artificial intelligence that assists medical personnel and trained optometrist by inputting the person's fundus image and indicating the suspected symptoms of fundus diseases (cataract , glaucoma, retinal disease) and predicting cardiovascular risk.

HSA registration DE0506438 · filed by Mediwhale Inc.

AmCAD‐ UT® Detection is a Windows‐based computer‐aided detection (CADe) device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA-cleared ultrasound systems, with user‐selected regions of interest (ROI). After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules for which a biopsy recommendation is required.”

HSA registration DE0506347 · filed by AmCad BioMed Corporation

AI-Rad Companion (Musculoskeletal) is intended to assist the physician in evaluating the spine. AI- Rad Companion (Musculoskeletal) is an image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of musculoskeletal disease. It provides the following functionality: • Segmentation of vertebras • Labelling of vertebras • Measurements of heights in each vertebra and indication if they are critically different • Measurement of mean Hounsfield value in volume of interest within vertebra. Only DICOM images of adult patients are considered to be valid input.

HSA registration DE0506332 · filed by Siemens Healthcare GmbH

AI-Rad Companion Prostate MR is a post-processing image analysis software that assists clinicians in viewing, manipulating, analyzing, and evaluating MR prostate images for US-guided MR-US fusion biopsy planning. AI-Rad Companion Prostate MR provides the following functionalities. • Automatic segmentation and quantitative analysis of the prostate gland • Manual annotation of relevant findings • Presentation and export of results for further processing and reporting

HSA registration DE0506272 · filed by Siemens Healthcare GmbH

AI-Rad Companion Brain MR is a post-processing image analysis software that assists clinicians in viewing, analyzing, and evaluating MR brain images. AI-Rad Companion Brain MR provides the following functionalities. • Automatic segmentation and quantitative analysis of individual brain structures • Quantitative comparison of each brain structure with normative data from a healthy population • Presentation of results for reporting that includes all numerical values as well as visualization of these results

HSA registration DE0506231 · filed by Siemens Healthcare GmbH

Lunit INSIGHT MMG/DBT is a Computer-Assisted Detection/Diagnosis (CAD) software device based on an artificial intelligence algorithm intended to aid in the detection, localization, identification, and characterization of suspicious areas for breast cancer on mammograms. As an adjunctive tool, the device is intended to be viewed by interpreting physicians and it is not intended as a replacement for a complete clinician’s review or their clinical judgement that takes into account other relevant information from the image or patient history. Lunit INSIGHT MMG/DBT is intended for use in screening mammograms to identify and characterize suspicious areas for breast cancer for interpreting physicians’ review.

HSA registration DE0506109 · filed by Lunit Inc.

The CARES4WOUNDS C4W-B system is intended to be used for wound imaging, automatic measurement of wound dimensions, and tissue classification to aid in the assessment of pressure ulcers, diabetic ulcers and venous ulcers.

HSA registration DE0505980 · filed by Tetsuyu Healthcare Holdings Pte Ltd

ClearRead CT is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations of the chest on an asymptomatic population. The ClearRead CT requires both lungs be in the field of view. ClearRead CT provides adjunctive information and is not intended to be used without the original CT series.

HSA registration DE0505903 · filed by Riverain Technologies, Inc.

AI-Rad Companion (Cardiovascular) is intended to assist the physician in evaluating the heart and the aorta in non-cardiac chest CT data sets. It is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of cardiovascular diseases. It provides the following functionality: (1) Segmentation and volume measurement of the heart. (2) Quantification of the total calcium volume in the coronary arteries. (3) Segmentation of the aorta. (4) Measurement of maximum diameters of the aorta at typical landmarks, and (5) Threshold-based highlighting of enlarged diameters.

HSA registration DE0505833 · filed by Siemens Healthcare GmbH

It is a Computer-Assisted Detection (CAD) software device based on an artificial intelligence algorithm intended for use as a concurrent reading aid for interpreting physicians reading chest radiographs, to detect, localize, identify, and characterize suspicious abnormal radiological findings. As an adjunctive tool, the device is intended to be viewed by interpreting physicians and it is not intended as a replacement for a complete clinician’s review or their clinical judgement that considers other relevant information from the image or patient history. It analyzes chest radiographs using machine learning techniques to identify and characterize suspicious areas for abnormal radiologic findings The device identifies suspicious areas of abnormal radiologic findings including atelectasis, calcification, cardiomegaly, consolidation, fibrosis, mediastinal widening, nodule, pneumothorax, pleural effusion and pneumoperitoneum on chest radiographs

HSA registration DE0505722 · filed by Lunit Inc.

Critical Care Suite is a computer aided triage and notification device that analyzes frontal chest xray images for the presence of prespecified critical findings (pneumothorax). Critical Care Suite identifies images with critical findings to enable case prioritization in the PACS/workstation. Critical Care Suite is intended for notification only and does not provide diagnostic information beyond the notification. Critical Care Suite should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. It is not intended to replace the review of the xray image by a qualified physician. Critical Care Suite is indicated for adult-size patients.

HSA registration DE0505081 · filed by GE Medical Systems LLC

An image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard “off-the-shelf” computer, or, a virtual platform such as VMware, and, can be used to perform image viewing, processing and analysis of brain images. Data and images are acquired through DICOM compliant imaging devices. iSchemaView RAPID provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module. The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume.

HSA registration DE0503930 · filed by iSchemaView, Inc.

EyRIS SELENA+ is an automated system through the analysis of colour fundus retinal images, intended for use by healthcare professionals, to detect diabetic patients at risk of vision loss. EyRIS SELENA+ can automatically detect more than mild diabetic retinopathy (DR) using the International Clinical Diabetic Retinopathy Disease Severity Scale (ICDRSS) and diabetic macular edema (DME), referable/non-referable glaucoma suspect and referable/non-referable age-related macular degeneration (AMD), in the eyes of adults diagnosed with diabetes. The output is intended to help healthcare providers decide which diabetic patients need referral to an eye care provider for further evaluation and management.

HSA registration DE0503735 · filed by EyRIS Pte Ltd

KroniKare Wound Scanner is a diagnostic tool for AI-based chronic wound assessment, providing wound measurement, wound tissue type classification (all 7 medically-assessed tissues) and ischemia detection, as well as triaging alerts for infection, undermining, and inflammation, to complement the information provided to experts for final decisions and diagnosis. KroniKare Wound Scanner is intended for use on chronic wounds by trained users who are competent in using the application and the results should be interpreted by experts. Experts are clinical staff familiar with chronic wound assessment and management, including wound nurses, wound care specialists, and vascular surgeons.

HSA registration DE0503713 · filed by Kronikare Pte ltd

The DR Grading software is intended to screen and grade Diabetic Retinopathy (DR) in patients/general population through colour fundus retinal images. The DR Grader is indicated for use by health care providers to automatically detect and grade diabetic retinopathy in patients who have been diagnosed with diabetes and screen those who have not yet been diagnosed with diabetes.

HSA registration DE0502936 · filed by TELEMEDC PTE LTD