Modality
68 source-backed listings mapped to this modality. Use each profile to verify FDA file number, workflow fit, integration, deployment, and unknown fields.
Therapixel
Flags calcifications, masses, asymmetries and architectural distortions on compatible FFDM or DBT screening examinations; management must not be based solely on MammoScreen output.
DeepHealth, Inc.
Concurrent detection and characterization support for screening DBT mammography
DeepHealth, Inc.
BAC processes screening FFDM and DBT mammograms to detect the presence or absence of breast arterial calcifications at study and breast level and localize detected calcifications...
Neurocareai, Inc. (Dba Savelife.Ai)
Tags screening cases as suspicious or blank to aid worklist prioritization; radiologists must review every examination and it does not mark original images.
Lunit, Inc.
Lunit INSIGHT MMG v1.1.10 aids physicians in detection, localization and characterization of suspicious breast-cancer areas on female screening mammograms from compatible FFDM...
Lunit, Inc.
Concurrent CADe/x aid for interpreting physicians to detect and characterize breast-cancer-suspicious lesions in screening DBT exams from compatible systems, marking soft-tissue...
Medcognetics, Inc.
Prioritizes suspicious screening DBT examinations for MQSA interpreting physicians; every examination remains subject to full physician review.
GE Healthcare
Senographe Pristina 3D PMA supplement S005 updates digital breast tomosynthesis reconstruction with deep learning to correct sparse-view artifacts, compensate patient motion, and...
Therapixel
MammoScreen BD evaluates 2D mammography standard views (CC and/or MLO) from compatible FFDM and/or 2D synthetic mammography from DBT to assign an ACR BI-RADS 5th Edition...
DeepHealth, Inc.
Saige-Dx analyzes screening DBT stacks and associated full-field digital or synthetic 2D mammograms, assigning finding and case suspicion levels to support qualified interpreting...
Hologic, Inc.
Genius AI Detection 2.0 analyzes compatible digital breast tomosynthesis exams to identify and mark soft-tissue densities (masses, architectural distortions, asymmetries) and...
Therapixel
Identifies calcifications, masses, asymmetries and architectural distortions on compatible FFDM or DBT screening examinations; it is not a standalone diagnostic device.
Clairity, Inc.
Allix5 generates a five-year breast-cancer-risk prediction from bilateral screening mammograms for eligible patients without known breast cancer at presentation; it is not...
CureMetrix, Inc.
cmAngio (V1.6) processes screening mammograms to aid a qualified interpreting physician in the manual process of identifying breast arterial calcification. It detects the presence...
DeepHealth, Inc.
Concurrent reading aid for qualified interpreting physicians on screening DBT mammograms to identify soft-tissue lesions and calcifications that may indicate cancer and assign...
DeepHealth, Inc
Adjunctive assignment of a BI-RADS 5th Edition breast-density category for interpreting-physician review of mammography.
ScreenPoint Medical B.V.
Transpara 2.1.0 is a concurrent reading aid for physicians interpreting screening full-field digital mammography and digital breast tomosynthesis, providing region and examination...
DeepHealth, Inc
Concurrent reading aid for interpreting physicians on screening DBT mammograms to detect and characterize soft-tissue lesions and calcifications that may indicate cancer.
iCAD, Inc.
Concurrent CAD/CADx aid for interpreting physicians reading compatible DBT exams to detect soft-tissue densities and calcifications for physician confirmation or dismissal.
Lunit Inc.
Concurrent CADe/x aid for interpreting physicians to detect and characterize breast-cancer-suspicious lesions in screening DBT exams from compatible systems.
Therapixel
Adjunctively assess breast tissue composition and provide an ACR BI-RADS 5th Edition breast-density category for asymptomatic women aged 40 years or older undergoing screening...
SIEMENS MEDICAL SOLUTIONS USA, INC.
The FDA PMA supplement record identifies MAMMOMAT B.brilliant with Tomosynthesis Option as digital breast tomosynthesis and approves a new PREMIA reconstruction algorithm, updated...
Therapixel
Concurrent reading and reporting aid for physicians interpreting screening mammograms on compatible full-field digital mammography and digital breast tomosynthesis systems,...
VinBigData Joint Stock Company
The VinDr-Mammo is a passive notification for prioritization-only, a parallel- workflow software tool used by MQSA qualified interpreting physicians to prioritize patients with...
Screenpoint Medical B.V.
Automatically determine volumetric breast density, breast volume, and an ACR BI-RADS 5th Edition breast-density category from compatible digital mammography and digital breast...
Lunit Inc.
Concurrent CADe/x aid for interpreting physicians to detect and characterize suspected breast-cancer lesions in screening DBT exams from compatible systems.
CureMetrix, Inc.
cmAngio processes screening FFDM and DBT mammograms to detect presence or absence of breast arterial calcifications at study and breast level and mark segments for qualified...
Hologic, Inc.
Genius AI Detection is a computer-aided detection and diagnosis (CADe/CADx) software device intended to be used with compatible digital breast tomosynthesis (DBT) systems to...
Elaitra Ltd
ViewFinder is a dedicated softcopy review environment for both screening and diagnostic digital breast tomosynthesis. Its user interface and workflow have been optimized to...
DeepHealth, Inc.
Saige-Density is a software application intended for use with compatible full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) systems. Saige-Density...
Hologic, Inc.
Genius AI Detection 2.0 analyzes compatible digital breast tomosynthesis images to identify and mark soft-tissue densities and calcifications with confidence scores and case...
MedCognetics, Inc.
The MedCognetics (CogNet) QmTRIAGE TM software is a passive notification for prioritization-only, parallel-workflow software tool used by MQSA qualified interpreting physicians to...
ScreenPoint Medical B.V.
Transpara@ software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis...
DeepHealth, Inc.
Concurrent reading aid for interpreting physicians on screening mammograms with compatible DBT hardware; it analyzes DBT stacks and accompanying full-field digital or synthetic 2D...
Carestream Health, Inc.
The software performs digital enhancement of a radiographic image generated by an x-ray device. The software can be used to process adult and pediatric x-ray images. This excludes...
TaiHao Medical Inc.
Assist trained interpreting physicians in analyzing breast-ultrasound images of patients with soft-tissue breast lesions suspicious for cancer who are referred for further...
Therapixel
MammoScreen is intended for use as a concurrent reading aid for interpreting physicians, to help identify findings on screening FFDM or DBT acquired with compatible mammography...
Lunit Inc.
Aid interpreting physicians in detecting, localizing, and characterizing suspicious breast-cancer areas on mammograms from compatible FFDM systems, viewed after the physician...
ClariPi Inc.
Calculation of percent breast density and breast-density group information (BI-RADS A+B fatty versus C+D dense) as adjunctive information for interpreting physicians assessing...
Olea Medical
Visualization, analysis, reporting, lesion measurement, kinetic assessment, and MR-guided breast interventional planning; when interpreted by a skilled physician, information may...
Volpara Health Technologies Limited
Provides volumetric breast density, BI-RADS fourth- or fifth-edition density categories and dose/pressure quality metrics from raw mammography or DBT data as adjunctive...
iCAD, Inc.
PowerLook Density Assessment is a software application intended for use with digital breast tomosynthesis synthesized2D images from tomosynthesis exams. PowerLook Density...
ScreenPoint Medical B.V.
Transpara software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis...
DeepHealth, Inc.
Saige-Q is a software workflow tool designed to aid radiologists in prioritizing exams within the standard-of-care image worklist for compatible FFDM and DBT screening mammograms....
iCAD Inc.
Concurrent or secondary CAD assistance to interpreting physicians for detection, localization, and characterization of soft-tissue densities (masses, architectural distortions,...
Visage Imaging GmbH
Visage Breast Density is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. Visage Breast Density...
Hologic, Inc.
Genius AI Detection analyzes compatible digital breast tomosynthesis images to identify and mark soft-tissue densities and calcifications with confidence scores and case scoring...
Whiterabbit.ai Inc.
WRDensity is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. WRDensity provides an ACR BI-RADS...
Zebra Medical Vision Ltd.
The Zebra HealthMammo is a passive notification for prioritization-only, parallel-workflow software tool used by MQSA-qualified interpreting physicians to prioritize patients with...
Therapixel
MammoScreen is a concurrent reading aid for interpreting physicians reviewing screening full-field digital mammography; it marks suspicious soft-tissue lesions and calcifications...
ScreenPoint Medical B.V.
Transpara version 1.6 is a concurrent screening aid for FFDM and DBT that presents suspicious-region marks, region scores from 0 to 100, and an exam score from 1 to 10 for...
Densitas, Inc.
Densitas densityai is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. Densitas densityai provides...
Screenpoint Medical B.V.
Transpara version 1.5 is a concurrent screening full-field digital mammography aid that presents suspicious-region marks and scores for physician review and cannot be used as the...
iCAD Inc.
ProFound AI V2.1 Software is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while reading digital...
Koios Medical, Inc.
Adjunctive breast-cancer decision support during diagnostic ultrasound for patients referred for further diagnostic ultrasound; classifies a user-selected lesion ROI into four...
CureMetrix, Inc
Passive, prioritization-only notification of 2D FFDM screening mammograms with at least one suspicious finding at the exam level; not diagnostic.
iCAD Inc.
PowerLook® Tomo Detection V2 Software is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while...
ScreenPoint Medical BV
Transpara is a concurrent reading aid for screening mammograms that marks suspicious regions, lesions, and calcifications and provides malignancy scores for qualified physician...
Volpara Health Technologies Limited
Volpara Imaging Software processes raw digital breast X-ray and tomosynthesis data to calculate breast-density maps, volumetric density, and a BI-RADS density category as an...
Statlife
Adjunctive estimation of the BI-RADS 5th Edition breast-density category from processed digital 2D mammograms to aid radiologists; not diagnostic.
Densitas, Inc.
DM-Density is a software application intended for use with compatible full field digital mammography systems. DMDensity calculates percent breast density defined as the ratio of...
HOLOGIC, INC.
Quantra 2.2 analyzes digital breast X-ray images and categorizes breast density to provide additional information for a radiologist's assessment.
iCAD Inc
Concurrent computer-aided detection for radiologists interpreting compatible GE Senoclaire breast tomosynthesis examinations, with detected soft-tissue densities blended into the...
Matakina Technology LTD
Volpara processes raw data from digital breast x-ray systems, including tomosynthesis, to calculate density maps, volumetric breast density, and BI-RADS breast-density categories...
HOLOGIC, INC.
Quantra version 2.1 calculates volumetric and area breast-density measures and density categories from supported digital mammography images as an adjunct, not a diagnostic result.
HOLOGIC, INC.
Quantra version 1.1 calculates a volumetric breast-density ratio from supported Hologic full-field digital mammography images on the Cenova server as an adjunct, not a diagnostic...
ICAD, INC.
The Second Look computer-aided detection system for mammography is intended to identify and mark regions of interest on standard mammographic views after the initial reading has...
Hologic, Inc.
The ImageChecker M1000 is a computer system intended to identify and mark regions of interest on routine screening mammograms after the initial reading has been completed,...