510(k) Report

Devices descending from DEN170073

128 later devices reach ContaCT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251590Methinks CTA StrokeMethinks Software, S.L20250—
+1K223042Viz LVO ContaCTViz. Ai, Inc.20223—
+1K212261StrokeSENS LVOCircle Neurovascular Imaging, Inc.20210—
+1K200873HALONico-Lab B.V.20201—
+1K193658Viz ICHViz. Ai, Inc.20207—
+1K192383BriefCaseAidoc Medical, Ltd.201918—
+1K182875DeepCTDeep01 Limited20190—
+1K183285cmTriageCuremetrix, Inc.201937—
+1K182177AccipiolxMaxq-Al, Ltd.20187—
+1K180647BriefCaseAidoc Medical, Ltd.201873—
+2K251610qER-CTA (v1.0)Qure.Ai Technologies20250—
+2K243363JLK-IchJLK, Inc.20250—
+2K241480JBS-LvoJLK, Inc.20240—
+2K240353Hyper Insight - ICHSk, Inc.20240—
+2K231837Brainomix 360 Triage LVOBrainomix Limited20230—
+2K231195Brainomix 360 Triage ICHBrainomix Limited20230—
+2K203260syngo.CT Brain HemorrhageSiemens Medical Solutions USA, Inc.20222—
+2K211179InferRead CT Stroke.AIInfervision Medical Technology Co., Ltd.20215—
+2K211788HALONicolab B.V.20210—
+2K203517Saige-QDeepHealth, Inc.20211—
+2K210209Viz ICHViz. Ai, Inc.20213—
+2K203508BriefCaseAidoc Medical, Ltd.202017—
+2K201310AccipiolxMaxq AL, Ltd.20200—
+2K200905HealthMammoZebra Medical Vision, Ltd.20203—
+2K200855CINAAvicenna.Ai20208—
+2K193298BriefCaseAidoc Medical, Ltd.202020—
+2K200921qERQure.Ai Technologies20201—
+2K192901HealthVCFZebra Medical Vision, Ltd.20206—
+2K193351NinesAINines, Inc.20201—
+2K192167CuraRad-ICHCuracloud Corp.20201—
+2K193087Rapid ICHIschemaview Incorporated20207—
+2K190424HealthICHZebra Medical Vision, Ltd.20190—
+2K190896BriefCaseAidoc Medical, Ltd.201919—
+2K190362HealthPNXZebra Medical Vision, Ltd.201923—
+2K190072BriefCaseAidoc Medical, Ltd.201930—
+3K252954MammoSightAINeurocareai, Inc. (Dba Savelife.Ai)20260—
+3K253163Efai Ersuite CT Appendicitis Assessment System (Appen-CT-100)Ever Fortune.Ai, Co., Ltd.20260—
+3K250694Scaida BrainCT-ICH (v1.0)Mlhealth 36020250—
+3K253265BriefCase-TriageAidoc Medical, Ltd.20250—
+3K241923EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)Ever Fortune.Ai, Co., Ltd.20240—
+3K241719NeuroICHNeurocareai, Inc.20240—
+3K242837BriefCase-TriageAidoc Medical, Ltd.20240—
+3K240942CINA-CSpineAvicenna.Ai20240—
+3K232431syngo.CT Brain HemorrhageSiemens Medical Solutions USA, Inc.20241—
+3K231025EFAI NeuroSuite CT ICH Assessment SystemEver Fortune.Ai, Co., Ltd.20230—
+3K231384Annalise Enterprise CTB Triage TraumaAnnalise-Ai Pty, Ltd.20230—
+3K223240Annalise Enterprise CTB Triage TraumaAnnalise-Ai Pty, Ltd.20233—
+3K222884Rapid NCCT StrokeIschemaview, Inc.20235—
+3K221868QOCA image Smart CXR Image Processing SystemQuanta Computer, Inc.20230—
+3K222692BriefCaseAidoc Medical, Ltd.20221—
+3K221716CINAAvicenna.Ai20221—
+3K221330BriefCaseAidoc Medical, Ltd.20221—
+3K220709BriefCaseAidoc Medical, Ltd.20222—
+3K220080CogNet QmTRIAGEMedcognetics, Inc.20222—
+3K221456Rapid ICHIschemaview, Inc.20222—
+3K221241DrAid for Radiology v1Vinbrain Joint Stock Company20220—
+3K222277BriefCaseAidoc Medical, Ltd.20221—
+3K220439Viz SDHViz. Ai, Inc.20221—
+3K221314BriefCaseAidoc Medical, Ltd.20221—
+3K220499Rapid PE Triage and Notification (PETN)Ischemaview, Inc.20221—
+3K221240BriefCaseAidoc Medical, Ltd.20221—
+3K213886BriefCaseAidoc Medical, Ltd.20222—
+3K213721BriefCaseAidoc Medical, Ltd.20221—
+3K210237Cina ChestAvicenna.Ai20215—
+3K202992BriefCase, RIB Fractures Triage (RibFx)Aidoc Medical, Ltd.20212—
+3K193271uAI EasyTriage-RibShanghai United Imaging Intelligence Co., Ltd.20213—
+3K201020BriefCaseAidoc Medical, Ltd.202018—
+3K200941Rapid LVOIschemaview, Inc.20203—
+3K193300AIMI-Triage CXR PTXRadlogics, Inc.20202—
+3K191556Red DotBehold.Ai Technologies Limited20206—
+3K192320HealthCXRZebra Medical Vision, Ltd.20199—
+3K183182Critical Care SuiteGe Medical Systems, LLC20198—
+4K260729Vascular Assist Occlusion Triage (VAOT) (v1.0)GuideAI Health20260—
+4K261317BriefCase-TriageAidoc Medical, Ltd.20260—
+4K252421JLK-NCCTJLK, Inc.20260—
+4K253818Annalise EnterpriseHarrison-AI Medical Pty, Ltd.20260—
+4K251195BriefCase-TriageAidoc Medical, Ltd.20260—
+4K252482CogNet AI-MT+Medcognetics, Inc.20250—
+4K252366a2z-Unified-TriageA2z Radiology Ai, Inc.20251—
+4K251151Rapid CTA 360Ischemaview20251—
+4K250685Methinks NCCT StrokeMethinks Software, S.L20250—
+4K243145syngo.CT LVO DetectionSiemens Medical Solutions USA, Inc.20250—
+4K243611JLK-SDHJLK, Inc.20250—
+4K242821EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)Ever Fortune.Ai, Co., Ltd.20250—
+4K250248BriefCase-TriageAidoc Medical, Ltd.20250—
+4K242292uAI Easy Triage ICHShanghai United Imaging Intelligence Co., Ltd.20240—
+4K241727BriefCase-TriageAidoc Medical, Ltd.20240—
+4K240612Cina-VCFAvicenna.Ai20240—
+4K233108VinDr-MammoVinbigdata Joint Stock Company20240—
+4K233247Heuron ICHHeuron Co., Ltd.20240—
+4K233968CINA-iPEAvicenna.Ai20240—
+4K232496Brainomix 360 Triage StrokeBrainomix Limited20231—
+4K232751BriefCase-TriageAidoc Medical, Ltd.20230—
+4K232436Rapid SDHIschemaview, Inc.20231—
+4K231767Annalise Enterprise CTB Triage TraumaAnnalise-Ai Pty, Ltd.20230—
+4K231094Annalise Enterprise CTB Triage-OHAnnalise-Ai Pty, Ltd.20230—
+4K230020BriefCaseAidoc Medical, Ltd.20231—
+4K221552EFAI ChestSuite XR Pneumothorax Assessment SystemEver Fortune.Ai, Co., Ltd.20220—
+4K222329BriefCaseAidoc Medical, Ltd.20224—
+4K222076EFAI ChestSuite XR Pleural Effusion Assessment SystemEver Fortune.Ai, Co., Ltd.20220—