510(k) Report

Devices descending from K212758

3 later devices reach Autoplaque through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+1K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+2K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—