510(k) Report

Devices descending from K203726

5 later devices reach ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212959ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) CatheterSiemens Medical Solutions USA, Inc.20214—
+2K261696ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc.20260—
+2K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+3K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+3K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—