Modality
67 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.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
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
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
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.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
DeepHealth, Inc
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
iCAD, Inc.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
Lunit Inc.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
Therapixel
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
VinBigData Joint Stock Company
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
Screenpoint Medical B.V.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Lunit Inc.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
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.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
Elaitra Ltd
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
DeepHealth, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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.
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
ScreenPoint Medical B.V.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
DeepHealth, Inc.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
Carestream Health, Inc.
FDA product code MQB identifies this device class as Solid State X-Ray Imager (Flat Panel/Digital Imager). Consult the linked FDA record for the exact authorized indications for...
Therapixel
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
Lunit Inc.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
ClariPi Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
ScreenPoint Medical B.V.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
DeepHealth, Inc.
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
iCAD Inc.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
Visage Imaging GmbH
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Zebra Medical Vision Ltd.
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
Arterys Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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.
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
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.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
Koios Medical, Inc.
FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...
CureMetrix, Inc
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
iCAD Inc.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
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
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
Densitas, Inc.
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
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
PowerLook Tomo Detection Software is a concurrent computer-aided detection tool for radiologists reading GE Senoclaire breast tomosynthesis examinations; it detects soft-tissue...
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,...