510(k) Report

Devices descending from K802146

15 later devices reach Aquasonic 100 Ultrasound Trans. Gel, through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121311Thixo-Gel Ultrasound SprayCloverline International Pharma Services GmbH20122—
+1K072515Embrace GelOrison Corporation200710—
+1K030889Ultraekogel Models EK 2000 & EK 2001Inmed Ltda.20030—
+2K131905Solid Gel PadBluemtech20131—
+2K120882Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc.20128—
+2K102683The AdditionOb The-Addition, LLC20110—
+3K252337EdgeFlow Gel PadEdgecare, Inc.20260—
+3K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc.201561
+3K150529Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound SystemC.R. Bard, Inc.20150—
+4K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+4K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechC. R. Bard20184—
+5K231283SiteRite™ 9 Ultrasound SystemBard Access Systems, Inc. (C.R. Bard, Inc.)20230—
+5K211193BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.)20212—
+6K251673X9 Ultrasound SystemX9, Inc.20250—
+6K240146BD Prevue™ II Peripheral Vascular Access SystemBard Access Systems, Inc.20240—