Use case
A buyer-oriented shortlist for breast imaging. Confirm exact intended use and local validation needs before any pilot or procurement decision.
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...
Shanghai United Imaging Healthcare Co., Ltd.
uOmnispace.MR provides viewing, manipulation, evaluation, and analysis of MR images, including labeled breast, brain, perfusion, vessel, cardiac, diffusion, susceptibility,...
Shanghai United Imaging Healthcare Co., Ltd.
uMI Panvivo variants acquire and display PET and CT information for anatomical and functional imaging, radiopharmaceutical distribution, attenuation correction, and the labeled...
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...
QT Imaging Holdings, Inc.
QT Scanner 2000 Model A uses ultrasonic reflection and transmission imaging to calculate fibroglandular tissue volume and the fibroglandular-tissue-to-total-breast-volume ratio in...
Ge Medical Systems, LLC
SIGNA Bolt is a whole-body MRI system for high-resolution diagnostic imaging of the labeled body regions, with supported AI-assisted reconstruction, positioning, and protocol...
Ge Medical Systems, LLC
SIGNA Sprint Select is a whole-body MRI system for diagnostic imaging of the labeled body regions, with supported AI-assisted reconstruction, positioning, and protocol functions.
Therapanacea Sas
ART-Plan+ assists trained radiation-therapy professionals with multimodal image review, registration, contouring, and the release-specific planning functions described in K253091....
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...
Ge Medical Systems Ultrasound and Primary Care Diagnostics
LOGIQ E10 is a general diagnostic ultrasound system for qualified users across fetal and obstetric, abdominal, gynecologic, pediatric, small-organ, breast, cardiac, vascular,...
Shanghai United Imaging Healthcare Co., Ltd.
uDR Aurora CX acquires two-dimensional X-ray images of the labeled skull, spine, chest, abdomen, extremities, limbs, and trunk for review by qualified healthcare professionals; it...
GE Medical Systems, LLC
SIGNA Sprint is a 1.5T whole-body MRI system for diagnostic imaging of the labeled head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, vessels, 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...
Shanghai United Imaging Healthcare Co., Ltd.
uMI Panvivo and Panvivo S acquire and display PET and CT information for anatomical and functional imaging, radiopharmaceutical distribution, and the labeled oncology, cardiology,...
Siemens Medical Solutions
LUMINOS Q.namix T and LUMINOS Q.namix R are multifunctional radiography and fluoroscopy systems for routine radiography and fluoroscopic examinations including gastrointestinal,...
SimBioSys, Inc.
TumorSight Viz processes dynamic contrast-enhanced breast MRI for patients with biopsy-proven early-stage or locally advanced breast cancer, providing registration, subtraction,...
Therapixel
Identifies calcifications, masses, asymmetries and architectural distortions on compatible FFDM or DBT screening examinations; it is not a standalone diagnostic device.
Esaote S.p.A.
The 6600 Ultrasound System is a multifunctional diagnostic ultrasound scanner that collects, displays, and analyzes ultrasound images during ultrasound imaging procedures with...
Philips Ultrasound LLC
EPIQ and Affiniti are diagnostic ultrasound systems for imaging and fluid-flow analysis of the human body across the labeled abdominal, cardiac, vascular, fetal, gynecologic,...
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...
FUJIFILM Corporation
Synapse 3D Base Tools assists trained professionals with reading, interpreting, reporting, and treatment planning from DICOM data from CT, MR, CR, US, NM, PT, XA, and other...
Philips Ultrasound LLC
EPIQ and Affiniti are diagnostic ultrasound systems for imaging and fluid-flow analysis of the human body across the labeled abdominal, cardiac, vascular, fetal, gynecologic,...
Esaote S.p.A.
The 6450 Ultrasound System is a multifunctional diagnostic ultrasound scanner for collecting, displaying, and analyzing ultrasound images with supported probes; Virtual Navigator...
Philips Ultrasound LLC
EPIQ and Affiniti are diagnostic ultrasound systems for imaging and fluid-flow analysis of the human body across the labeled abdominal, cardiac, vascular, fetal, gynecologic,...
GE Medical Systems SCS
VersaViewer supports two-dimensional, three-dimensional, and four-dimensional medical-image series processing and analysis through customizable layouts, multimodality review, and...
Philips Ultrasound LLC
EPIQ and Affiniti are diagnostic ultrasound systems for imaging and fluid-flow analysis of the human body across the labeled abdominal, cardiac, vascular, fetal, gynecologic,...
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...
GE Medical Systems, LLC
SIGNA Prime Elite is a whole-body MR system that produces cross-sectional, spectroscopic, parametric, and dynamic images of the labeled body regions for trained physician...
Philips Ultrasound LLC
EPIQ and Affiniti are diagnostic ultrasound systems for imaging and fluid-flow analysis of the human body across the labeled abdominal, cardiac, vascular, fetal, gynecologic,...
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.
Koios Medical, Inc.
Koios Decision Support (DS) is an artificial intelligence (AI)/machine learning (ML)-based computer-aided diagnosis (CADx) software device intended for use as an adjunct to...
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.
SimBioSys, Inc.
Visualize and analyze DCE breast MRI studies for patients with biopsy-proven early-stage or locally advanced breast cancer, including processing, measurements, and configurable...
MVision AI Oy
Contour+ generates initial CT and MR anatomical contours across head and neck, brain, breast, thoracoabdominal, and pelvic radiation-treatment planning workflows for qualified...
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...
GE Medical Systems Israel, Functional Imaging
Omni Legend is a PET/CT system for attenuation-corrected PET with positron-emitting radiopharmaceuticals across whole-body, head, heart, brain, lung, breast, bone,...
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...
Shanghai United Imaging Healthcare Co., Ltd.
uOmnispace.MR is a software solution for viewing, manipulating, evaluating, and analyzing medical images within healthcare institutions. The FDA indication lists MR stitching,...
GE Healthcare (Tianjin) Company Limited
The SIGNA Champion is a whole-body magnetic resonance scanner indicated to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, spectra,...
Butterfly Network, Inc.
Butterfly iQ3 is a general-purpose portable ultrasound system for adult and pediatric imaging, peripheral vessels, small organs, breast, thyroid, scrotum, cardiac, abdominal,...
SimBioSys, Inc.
TumorSight Viz analyzes dynamic contrast-enhanced breast MRI for visualization and analysis of biopsy-proven early-stage or locally advanced breast cancer, including registration,...
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...
GE Medical Systems Ultrasound and Primary care Diagnostics
LOGIQ Totus is a general-purpose diagnostic ultrasound system for trained healthcare professionals to image, measure, display, and analyze the human body and fluid across the...
GE Medical Systems Ultrasound and Primary Care Diagnostic
LOGIQ E10s and LOGIQ Fortis are general-purpose diagnostic ultrasound systems for trained healthcare professionals to image, measure, display, and analyze the human body and fluid...
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...
Shanghai United Imaging Healthcare Co., Ltd
uOmnispace is software for viewing, manipulating, communicating, storing, processing, and filming multimodality DICOM images, usable stand-alone or with cleared software options...
FUJIFILM Healthcare Corporation
The ECHELON Synergy MRI system is a 1.5T MR imaging device that provides non-ionizing physiological and clinical information and produces transverse, coronal, sagittal, oblique,...
GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC
Voluson SWIFT and Voluson SWIFT+ are general-purpose diagnostic ultrasound systems for qualified and trained healthcare professionals to image, measure, display, and analyze the...
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...
University of Texas, MD Anderson Cancer Center
Radiation Planning Assistant creates initial CT-based contours and photon external-beam treatment plans for head-and-neck, cervical, breast, and whole-brain radiotherapy; every...
Philips Ultrasound LLC
The K231190 EPIQ submission adds the mL26-8 linear-array transducer for labeled high-resolution superficial, musculoskeletal, ophthalmic, pediatric, peripheral-vessel, breast,...
Subtle Medical Inc.
MRI image enhancement by reducing image noise for head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal MRI, or increasing image sharpness for head MRI.
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...
Synapsica
RadioLens v1.0 is a medical diagnostic application for displaying, processing, storing, and transferring DICOM data other than mammography, with filtering, digital manipulation,...
GE Healthcare (Tianjin) Company Limited
SIGNA Victor is a whole-body magnetic-resonance scanner for high-resolution imaging, high signal-to-noise ratio, and short scan times. It is indicated to produce axial, sagittal,...
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...
Siemens Medical Solutions USA, Inc.
Syngo Dynamics VA40F is a multimodality, vendor-agnostic cardiology image and information system for medical-image management and processing, with post-processing functions for...
Coreline Soft Co.,Ltd
AVIEW RT ACS is a medical image-management and processing system for radiation-treatment planning with deep-learning auto-segmentation evidence described in the exact FDA decision...
Shanghai United Imaging Healthcare Co.,Ltd.
The uMR Omega System is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and...
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...
Siemens Medical Solutions USA, Inc.
MAGNETOM Skyra Fit with syngo MR XA50A is a 3T system for broad head, body, and extremity MRI; this release includes TSE motion correction and automatic breast-biopsy fiducial...
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...
MVision AI
MVision AI Segmentation automatically generates initial contours from CT images for radiotherapy planning; the contours are transferred for professional visualization, review,...
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...
Koios Medical, Inc.
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...
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...
Change Healthcare Canada Company
Change Healthcare Anatomical AI is intended to analyze pixel data from CT or MR images to create comprehensive anatomic descriptors for export to integrated healthcare systems....
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....
Carestream Health, Inc.
Eclipse II with Smart Noise Cancellation digitally enhances radiographic images generated by supported X-ray devices for adult and pediatric use; the cleared function is for...
iCAD Inc.
Concurrent or secondary CAD assistance to interpreting physicians for detection, localization, and characterization of soft-tissue densities (masses, architectural distortions,...
Subtle Medical, Inc.
SubtleMR is MRI image-processing software for reducing noise in supported head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal MRI or increasing sharpness for...
Fujifilm Corporation
Synapse 3D Base Tools is medical-imaging software that provides trained medical professionals tools to aid reading, interpreting, reporting, and treatment planning. It accepts...
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...
Seno Medical Instruments, Inc.
Imagio combines ultrasound and optoacoustic imaging to evaluate palpable or non-palpable breast abnormalities in adults referred for diagnostic workup. Ultrasound can assign...
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...
TOMTEC Imaging Systems GmbH
TOMTEC-ARENA quantifies and reports cardiovascular, fetal, and abdominal structures and functions from supported clinical images and can exchange data with IMAGE-ARENA and...
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...
Shanghai United Imaging Healthcare Co., Ltd
uWS-MR provides MR image viewing, manipulation, communication, storage, stitching, fusion, spectroscopy, parameter maps, breast evaluation, brain perfusion, and related processing...
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.
GE Healthcare
Centricity Universal Viewer displays, communicates, stores, and processes supported medical images and related data for authorized users in clinical imaging workflows;...
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.
Agfa HealthCare N.V.
DR 800 with MUSICA Dynamic supports digital radiography and dynamic-fluoroscopy examinations including routine radiography, positioning, gastrointestinal, urogenital,...
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...
Philips Medical Systems Technologies, Ltd.
Illumeo is an image-management system for trained professionals, including radiologists. It is a software package used with general-purpose computing hardware to acquire, store,...
Microsoft Corp.
Microsoft Radiomics App v1.0 is a software-only medical device for trained radiation oncologists, dosimetrists, and physicists to derive organ and tumor contours for...
HOLOGIC, INC.
Quantra 2.2 analyzes digital breast X-ray images and categorizes breast density to provide additional information for a radiologist's assessment.
Clarius Mobile Health Corp.
Clarius Ultrasound Scanner is a software-based diagnostic ultrasound imaging system for trained healthcare professionals across labeled abdominal, thoracic, musculoskeletal,...
Quantitative Insights, Inc
QuantX is breast MRI software for the labeled management, analysis, visualization, and decision-support workflow; exact image inputs, outputs, and use remain submission-specific.
iCAD Inc
Concurrent computer-aided detection for radiologists interpreting compatible GE Senoclaire breast tomosynthesis examinations, with detected soft-tissue densities blended into the...
ClearView Diagnostics Inc.
ClearView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images. It automatically classifies shape and orientation...
QView Medical, Inc.
The QVCAD System is indicated as an aid to the reader during screening procedures in searching images of female breasts produced by the somo.v Automated Breast Ultrasound System,...
ALGOMEDICA
PixelShine is intended for networking, communication, processing, and enhancement of CT images in DICOM format to assist professional radiologists and specialists in reaching...
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.
SIEMENS MEDICAL SOLUTIONS USA, INC.
YSIO MAX is a digital radiography system for whole-body skull, chest, abdomen, and extremity imaging in pediatric, adult, and bariatric patients, including supported emergency and...
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,...