510(k) Report

Devices descending from K152554

6 later devices reach Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+1K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechC. R. Bard20184—
+2K231283SiteRite™ 9 Ultrasound SystemBard Access Systems, Inc. (C.R. Bard, Inc.)20230—
+2K211193BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.)20212—
+3K251673X9 Ultrasound SystemX9, Inc.20250—
+3K240146BD Prevue™ II Peripheral Vascular Access SystemBard Access Systems, Inc.20240—