510(k) Report

Devices descending from K193298

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253163Efai Ersuite CT Appendicitis Assessment System (Appen-CT-100)Ever Fortune.Ai, Co., Ltd.20260—
+1K253265BriefCase-TriageAidoc Medical, Ltd.20250—
+1K203508BriefCaseAidoc Medical, Ltd.202017—
+2K242837BriefCase-TriageAidoc Medical, Ltd.20240—
+2K221330BriefCaseAidoc Medical, Ltd.20221—
+2K220709BriefCaseAidoc Medical, Ltd.20222—
+2K222277BriefCaseAidoc Medical, Ltd.20221—
+2K221314BriefCaseAidoc Medical, Ltd.20221—
+2K221240BriefCaseAidoc Medical, Ltd.20221—
+2K213886BriefCaseAidoc Medical, Ltd.20222—
+2K213721BriefCaseAidoc Medical, Ltd.20221—
+3K260729Vascular Assist Occlusion Triage (VAOT) (v1.0)GuideAI Health20260—
+3K261317BriefCase-TriageAidoc Medical, Ltd.20260—
+3K251195BriefCase-TriageAidoc Medical, Ltd.20260—
+3K242821EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)Ever Fortune.Ai, Co., Ltd.20250—
+3K250248BriefCase-TriageAidoc Medical, Ltd.20250—
+3K241727BriefCase-TriageAidoc Medical, Ltd.20240—
+3K233247Heuron ICHHeuron Co., Ltd.20240—
+3K233968CINA-iPEAvicenna.Ai20240—
+3K231094Annalise Enterprise CTB Triage-OHAnnalise-Ai Pty, Ltd.20230—