510(k) Report

Devices descending from K203182

6 later devices reach SubtleMR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242334Ezra FlashEzra Ai, Inc.20250—
+1K223623SubtleMR (2.3.x)Subtle Medical, Inc.20233—
+1K230264Ezra FlashEzra Ai, Inc.20231—
+2K243250SubtleHD (1.x)Subtle Medical, Inc.20250—
+2K241681Overjet Image Enhancement AssistOverjet, Inc.20240—
+2K240290AiMIFY (1.x)Subtle Medical, Inc.20240—