510(k) Report

Devices descending from K192835

7 later devices reach ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+2K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+2K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+3K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+3K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+4K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+4K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—