FDA.reportPublic FDA data

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
102
Last updated
2026-06-16 06:05:41

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00628719409022Rho16 Bit Inc.Rho2026-06-05
03770018071121RayvolveAZMEDV 62026-06-04
03770018071138RayvolveAZMEDV 62026-06-04
03770018071145RayvolveAZMEDV 62026-06-04
G140ANNALISECONTAINER60Annalise Critical Care AIHARRISON-AI MEDICAL PTY LTDCXR - 2.4+2025-07-28
G140ANNALISEENTP50Annalise TriageHARRISON-AI MEDICAL PTY LTD3.6.0+2024-01-11
G140ANNALISEENTP60Annalise TriageHARRISON-AI MEDICAL PTY LTD3.10.0+2025-07-24
00860012425303RevealAI-LungPrecision Medical Ventures Inc.v1.x2026-05-29
00860015781918iCAC DeviceBunkerhill Health Inc.1.0.02026-05-31
06287194090220Rho16 Bit Inc.Rho2025-03-31
00850894007919IQ-UIP4DMEDICAL LIMITED2.0.02026-05-10
00852491008047ChestSuiteImagen Technologies, Inc.1.0.02026-04-15
00860007434716Cognet AIMedcognetics IncMT+2026-05-21
00860015781901CAC (Gated) AlgorithmBunkerhill Health Inc.12026-05-13
08800076000230Lunit INSIGHT DBTLunit Inc.1.22026-04-17
09120105730037KOALAIB Lab GmbHV2.052020-11-03
B720BX360EASPECTS1200e-ASPECTSBRAINOMIX LIMITED12.02025-10-15
B720BX360EASPECTS1210Brainomix e-ASPECTSBRAINOMIX LIMITED12.12026-03-30
B720BX360EASPECTS1410e-ASPECTSBRAINOMIX LIMITED14.12025-10-13
B720BX360EASPECTS1430e-ASPECTSBRAINOMIX LIMITED14.32026-05-06
B720BX360ECTA1200Brainomix 360 e-CTABRAINOMIX LIMITED12.02025-10-15
B720BX360ECTA1210Brainomix 360 e-CTABRAINOMIX LIMITED12.12026-03-30
B720BX360ECTA1410e-CTABRAINOMIX LIMITED14.12025-10-13
B720BX360ECTA1430e-CTABRAINOMIX LIMITED14.32026-05-06
B720BX360ECTP1200e-CTPBRAINOMIX LIMITED12.02025-10-15
B720BX360ECTP1210Brainomix 360 e-CTPBRAINOMIX LIMITED12.12026-03-30
B720BX360ECTP1410e-CTPBRAINOMIX LIMITED14.12025-10-13
B720BX360ECTP1430e-CTPBRAINOMIX LIMITED14.32026-05-06
B720BX360ELUNG230Brainomix 360 e-LungBRAINOMIX LIMITED2.32026-03-30
B720BX360EMRI1200e-MRIBRAINOMIX LIMITED12.02025-10-15
B720BX360EMRI1210Brainomix 360 e-MRIBRAINOMIX LIMITED12.12026-03-30
B720BX360EMRI1410e-MRIBRAINOMIX LIMITED14.12025-10-13
B720BX360EMRI1430e-MRIBRAINOMIX LIMITED14.32026-05-06
B720BX360TRIAGEICH1120Triage ICHBRAINOMIX LIMITED11.22025-10-15
B720BX360TRIAGELVO1120Triage LVOBRAINOMIX LIMITED11.22025-10-15
B720BX360TRIAGELVO1410Triage LVOBRAINOMIX LIMITED14.12025-10-16
B720BX360TRIAGELVO1430Triage LVOBRAINOMIX LIMITED14.32026-05-06
B720BX360TRIAGESTRO1430Triage StrokeBRAINOMIX LIMITED14.32026-05-06
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
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
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
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, L.L.C.2.12023-10-19
B720BX360TRIAGELVO1110Triage LVOBRAINOMIX LIMITED11.12023-10-03
00860007434709Cognet AIMedcognetics IncMT2023-09-11