510(k) Report

Devices descending from K200855

8 later devices reach CINA through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222884Rapid NCCT StrokeIschemaview, Inc.20235—
+1K221716CINAAvicenna.Ai20221—
+2K252421JLK-NCCTJLK, Inc.20260—
+2K253818Annalise EnterpriseHarrison-AI Medical Pty, Ltd.20260—
+2K250685Methinks NCCT StrokeMethinks Software, S.L20250—
+2K242292uAI Easy Triage ICHShanghai United Imaging Intelligence Co., Ltd.20240—
+2K232496Brainomix 360 Triage StrokeBrainomix Limited20231—
+3K251983Brainomix 360 Triage StrokeBrainomix Limited20250—