FDA.report

X-ray image interpretive software

Definition
An interpretive software program intended to be used to analyse non-dental x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].
GUDID devices
68
Last updated
2026-03-31 21:26:10

Related Product Codes

CodeDeviceSpecialtyClassDevices
LLZSystem, Image Processing, RadiologicalRadiology215
QASRadiological Computer-Assisted Triage And Notification SoftwareRadiology212
QIHAutomated Radiological Image Processing SoftwareRadiology29
QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For CancerRadiology28
QBSRadiological Computer Assisted Detection/Diagnosis Software For FractureRadiology27
QFMRadiological Computer-Assisted Prioritization Software For LesionsRadiology26
POKComputer-Assisted Diagnostic Software For Lesions Suspicious For CancerRadiology24
JAKSystem, X-Ray, Tomography, ComputedRadiology23
MYNAnalyzer, Medical ImageRadiology22
OEBLung Computed Tomography System, Computer-Aided DetectionRadiology21
SAORadiology Software For Opportunistic Evaluation Of Low Bone Mineral DensityRadiology21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00850008977541ProFound DetectionIcad, Inc.4.02026-03-23
09369900000857SalixARTRYA USA INC.Salix Central V1.X2026-02-17
09369998252183SalixARTRYA USA INC.Salix Coronary Plaque V1.X2026-02-17
B720BX360EASPECTS1420e-ASPECTSBRAINOMIX LIMITED14.22026-02-03
B720BX360ECTA1420e-CTABRAINOMIX LIMITED14.22026-02-03
B720BX360ECTP1420e-CTPBRAINOMIX LIMITED14.22026-02-03
B720BX360EMRI1420e-MRIBRAINOMIX LIMITED14.22026-02-03
B720BX360TRIAGESTRO142Triage StrokeBRAINOMIX LIMITED14.22026-02-03
09120105730464KOALAIB Lab GmbHV2.112022-01-11
B720BX360TRIAGESTRO141Triage StrokeBRAINOMIX LIMITED14.12025-11-28
B720BX360EASPECTS1400e-ASPECTSBRAINOMIX LIMITED14.02025-08-18
B720BX360ECTA1400e-CTABRAINOMIX LIMITED14.02025-08-18
B720BX360ECTP1400e-CTPBRAINOMIX LIMITED14.02025-08-18
B720BX360TRIAGEICH1400Triage ICHBRAINOMIX LIMITED14.02025-08-18
B720BX360TRIAGELVO1400Triage LVOBRAINOMIX LIMITED14.02025-08-18
B720BX360TRIAGESTRO1400Triage StrokeBRAINOMIX LIMITED14.02025-08-18
G140ANNALISEENTP60Annalise TriageANNALISE-AI PTY LTD3.10.0+2025-07-24
G140ANNALISECONTAINER60Annalise Critical Care AIANNALISE-AI PTY LTDCXR - 2.4+2025-07-28
B720BX360ELUNG220e-LungBRAINOMIX LIMITED2.22025-07-25
00850003095042InferRead Lung CT.AIInfervision Medical Technology Co., Ltd5.0.2.52025-05-23
00850894007902Imbio PHAImbio, LLC4.0.02025-04-21
B720BX360EASPECTS113e-ASPECTSBRAINOMIX LIMITED11.32025-04-15
B720BX360ELUNG210e-LungBRAINOMIX LIMITED2.12025-04-15
03770024774016SmartChestMILVUEV2.x.x2025-03-31
06287194090220Rho16 Bit Inc.Rho2025-03-31
B720BX360ECTA1130Brainomix 360 e-CTABRAINOMIX LIMITED11.32025-03-20
08720387058051TransparaScreenpoint Medical B.V.2.Y.Z2024-11-28
08800045800342VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link TriageVUNO Inc.VN-M-302024-11-19
03770018071060RayvolveAZMED42024-10-11
03770018071077RayvolveAZMED42024-10-11
03770018071084RayvolveAZMED42024-10-11
09120105730730IB Lab LAMAIB Lab GmbHV1.062024-08-12
B720BX360ELUNG100e-LungBRAINOMIX LIMITED1.02024-06-14
03770018071008RayvolveAZMED22024-06-10
08800076000162Lunit INSIGHT DBTLunit Inc.1.12024-04-09
08800076000179Lunit INSIGHT CXR TriageLunit Inc.1.02024-04-09
03770018071015Rayvolve AZMED22024-03-18
03770018071022RayvolveAZMED22024-03-18
G140ANNALISEENTP50Annalise TriageANNALISE-AI PTY LTD3.6.02024-01-11
08720299502352StrokeViewer PerfusionNICo-Lab B.V.12023-12-20
08720387058044TransparaScreenpoint Medical B.V.2.Y.Z2023-12-20
B720BX360TRIAGESTRO1120Triage StrokeBRAINOMIX LIMITED11.22023-12-07
08800076000148Lunit INSIGHT DBTLunit Inc.1.02023-12-01
00195278789365Critical Care SuiteGE MEDICAL SYSTEMS, INC.2.12023-10-19
B720BX360TRIAGELVO1110Triage LVOBRAINOMIX LIMITED11.12023-10-03
00860007434709Cognet AIMedcognetics IncMT2023-09-11
B720BX360EMRI1110e-MRIBRAINOMIX LIMITED11.12023-09-05
B720BX360TRIAGEICH1110Triage ICHBRAINOMIX LIMITED11.12023-09-05
B720BX360ECTP1110e-CTPBRAINOMIX LIMITED11.12023-07-06
08809244060137GenorayGenoray Co., Ltd.Zenis2023-06-14
00850894007766Imbio RV/LVImbio, LLC3.1.12023-04-28
00852491008030Aorta-CADImagen Technologies, Inc.1.0.02023-04-06
B720BX360EASPECTS1110e-ASPECTSBRAINOMIX LIMITED11.12023-04-06
B720BX360ECTA1110e-CTABRAINOMIX LIMITED11.12023-04-06
08720387058013TransparaScreenpoint Medical B.V.1.7.22023-03-03
00850894007728Imbio RV/LVImbio, LLC3.1.02023-02-22
00195278217981Critical Care SuiteGE MEDICAL SYSTEMS, INC.2.02022-05-04
08800076000056Lunit INSIGHT MMGLunit Inc.1.1.6.52022-04-28
08800076000124Lunit INSIGHT CXR TriageLunit Inc.1.0.0.02022-04-28
08720299502338StrokeViewer LVO detectionNICo-Lab B.V.3.12022-03-08
B885MAML2US0MammoScreenTHERAPIXELMAL2US2022-01-20
09120105730471KOALAIB Lab GmbHV2.112022-01-11
00850894007643Imbio RV/LVImbio, LLC3.0.02021-12-09
05700002173614RBkneeRadiobotics ApSv.1.2021-11-08
00850894007636Imbio RV/LVImbio, LLC2.12021-08-10
00852491008023Chest-CADImagen Technologies, Inc.1.0.02021-07-26
08719326450131TransparaScreenpoint Medical B.V.1.7.y2021-07-23
09120105730082KOALAIB Lab GmbHV2.052020-11-03