510(k) Report

Devices descending from K180647

73 later devices reach BriefCase through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211179InferRead CT Stroke.AIInfervision Medical Technology Co., Ltd.20215—
+1K203508BriefCaseAidoc Medical, Ltd.202017—
+1K200855CINAAvicenna.Ai20208—
+1K193298BriefCaseAidoc Medical, Ltd.202020—
+1K200921qERQure.Ai Technologies20201—
+1K193351NinesAINines, Inc.20201—
+1K193087Rapid ICHIschemaview Incorporated20207—
+1K193658Viz ICHViz. Ai, Inc.20207—
+1K192383BriefCaseAidoc Medical, Ltd.201918—
+1K182875DeepCTDeep01 Limited20190—
+1K190896BriefCaseAidoc Medical, Ltd.201919—
+1K190072BriefCaseAidoc Medical, Ltd.201930—
+2K253163Efai Ersuite CT Appendicitis Assessment System (Appen-CT-100)Ever Fortune.Ai, Co., Ltd.20260—
+2K250694Scaida BrainCT-ICH (v1.0)Mlhealth 36020250—
+2K253265BriefCase-TriageAidoc Medical, Ltd.20250—
+2K243363JLK-IchJLK, Inc.20250—
+2K241923EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)Ever Fortune.Ai, Co., Ltd.20240—
+2K242837BriefCase-TriageAidoc Medical, Ltd.20240—
+2K240942CINA-CSpineAvicenna.Ai20240—
+2K240353Hyper Insight - ICHSk, Inc.20240—
+2K231384Annalise Enterprise CTB Triage TraumaAnnalise-Ai Pty, Ltd.20230—
+2K231195Brainomix 360 Triage ICHBrainomix Limited20230—
+2K223240Annalise Enterprise CTB Triage TraumaAnnalise-Ai Pty, Ltd.20233—
+2K222884Rapid NCCT StrokeIschemaview, Inc.20235—
+2K221716CINAAvicenna.Ai20221—
+2K221330BriefCaseAidoc Medical, Ltd.20221—
+2K220709BriefCaseAidoc Medical, Ltd.20222—
+2K221456Rapid ICHIschemaview, Inc.20222—
+2K222277BriefCaseAidoc Medical, Ltd.20221—
+2K221314BriefCaseAidoc Medical, Ltd.20221—
+2K220499Rapid PE Triage and Notification (PETN)Ischemaview, Inc.20221—
+2K221240BriefCaseAidoc Medical, Ltd.20221—
+2K213886BriefCaseAidoc Medical, Ltd.20222—
+2K213721BriefCaseAidoc Medical, Ltd.20221—
+2K210237Cina ChestAvicenna.Ai20215—
+2K202992BriefCase, RIB Fractures Triage (RibFx)Aidoc Medical, Ltd.20212—
+2K210209Viz ICHViz. Ai, Inc.20213—
+2K201020BriefCaseAidoc Medical, Ltd.202018—
+2K200941Rapid LVOIschemaview, Inc.20203—
+3K260729Vascular Assist Occlusion Triage (VAOT) (v1.0)GuideAI Health20260—
+3K261317BriefCase-TriageAidoc Medical, Ltd.20260—
+3K252421JLK-NCCTJLK, Inc.20260—
+3K253818Annalise EnterpriseHarrison-AI Medical Pty, Ltd.20260—
+3K251195BriefCase-TriageAidoc Medical, Ltd.20260—
+3K252366a2z-Unified-TriageA2z Radiology Ai, Inc.20251—
+3K251151Rapid CTA 360Ischemaview20251—
+3K250685Methinks NCCT StrokeMethinks Software, S.L20250—
+3K242821EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)Ever Fortune.Ai, Co., Ltd.20250—
+3K250248BriefCase-TriageAidoc Medical, Ltd.20250—
+3K241719NeuroICHNeurocareai, Inc.20240—
+3K242292uAI Easy Triage ICHShanghai United Imaging Intelligence Co., Ltd.20240—
+3K241727BriefCase-TriageAidoc Medical, Ltd.20240—
+3K233247Heuron ICHHeuron Co., Ltd.20240—
+3K233968CINA-iPEAvicenna.Ai20240—
+3K232496Brainomix 360 Triage StrokeBrainomix Limited20231—
+3K232751BriefCase-TriageAidoc Medical, Ltd.20230—
+3K232436Rapid SDHIschemaview, Inc.20231—
+3K231767Annalise Enterprise CTB Triage TraumaAnnalise-Ai Pty, Ltd.20230—
+3K231094Annalise Enterprise CTB Triage-OHAnnalise-Ai Pty, Ltd.20230—
+3K230020BriefCaseAidoc Medical, Ltd.20231—
+3K222329BriefCaseAidoc Medical, Ltd.20224—
+3K220439Viz SDHViz. Ai, Inc.20221—
+3K221248Rapid LVOIschemaview, Inc.20220—
+4K260906a2z-Abdo-TriageA2z Radiology Ai, Inc.20260—
+4K261085Rapid Vessel Occlusion (Rapid VO)iSchemaview20260—
+4K251533Rapid Obstructive Hydrocephalus, Rapid OHIschemaview, Inc.20250—
+4K251983Brainomix 360 Triage StrokeBrainomix Limited20250—
+4K251406BriefCase-TriageAidoc Medical, Ltd.20252—
+4K243611JLK-SDHJLK, Inc.20250—
+4K243548BriefCase-TriageAidoc Medical, Ltd.20240—
+4K240291Efai Cardiosuite Cta Acute Aortic Syndrome Assessment SystemEver Fortune.Ai, Co., Ltd.20240—
+5K253578BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large…Aidoc Medical, Ltd.20260—
+5K252970BriefCase-Triage: CARE Multi-triage CT BodyAidoc Medical, Ltd.20260—