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.
Quantib 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...
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.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
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
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...
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,...
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...
Quibim S.L.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
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.
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...
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.
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...
See-Mode Technologies Pte. Ltd.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
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
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...
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.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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.
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...
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.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
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,...
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....
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.
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.
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...
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...
ScanMed, LLC
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
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.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
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.
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...
TaiHao Medical 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 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....
Olea Medical
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...
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.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
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
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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.
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
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...
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...
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.
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.
Agfa HealthCare N.V.
DR 800 with MUSICA Dynamic supports digital radiography and dynamic-fluoroscopy examinations including routine radiography, positioning, gastrointestinal, urogenital,...
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.
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
PowerLook Tomo Detection Software is a concurrent computer-aided detection tool for radiologists reading GE Senoclaire breast tomosynthesis examinations; it detects soft-tissue...
ClearView Diagnostics Inc.
ClearView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images.
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,...