510(k) Report

Devices descending from K211179

5 later devices reach InferRead CT Stroke.AI through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250694Scaida BrainCT-ICH (v1.0)Mlhealth 36020250—
+1K223240Annalise Enterprise CTB Triage TraumaAnnalise-Ai Pty, Ltd.20233—
+2K252366a2z-Unified-TriageA2z Radiology Ai, Inc.20251—
+2K231767Annalise Enterprise CTB Triage TraumaAnnalise-Ai Pty, Ltd.20230—
+3K260906a2z-Abdo-TriageA2z Radiology Ai, Inc.20260—