510(k) Report

Devices descending from K121772

15 later devices reach Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201583SmartCT R1.0Philips Medical Systems Nederland B.V.20211—
+1K170130Dynamic Coronary RoadmapPhilips Medical Systems Nederland B.V.20171—
+1K151598VesselNavigator Rel. 1.0Philips Medical Systems Nederland B.V.20158—
+1K142273EmboGuidePhilips Medical Systems Nederland B.V.20151—
+2K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.20260—
+2K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+2K172307Dynamic Coronary Roadmap 2.0Philips Medical Systems Nederland B.V.20170—
+2K160088Cydar EVCydar, Ltd.20167—
+3K222998F3Acrew Imaging, Inc.20230—
+3K212442Cydar EV (Series B) and Cydar EV MapsCydar, Ltd.20211—
+3K171829EndoNautTherenva Sas20173—
+4K252500CARA SystemCara Medical, Ltd.20260—
+4K212383EndoNautTherenva Sas20212—
+5K222070EndoNautTherenva Sas20221—
+6K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PADBrainlab AG20250—