510(k) Report

Devices descending from K852353

66 later devices reach DG 200/300 Digital Angiographic System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092639Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision…GE Medical Systems SCS200965—
+2K223152Vision 2, EVARVision, TrackVision 2, HeartVision 2GE Medical Systems SCS20220—
+2K210830VUZE SystemVuze Medical, Ltd.20221—
+2K152352Stereo 3D option for Vision ApplicationsGE Medical Systems SCS20161—
+2K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+2K130069Innova Epvision 2.0, Innova Epvision 2.0GE Healthcare20130—
+2K121772Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1Philips Medical Systems Nederland B.V.201315—
+2K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+3K232976VUZE SystemVuze Medical, Ltd.20240—
+3K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+3K201583SmartCT R1.0Philips Medical Systems Nederland B.V.20211—
+3K170130Dynamic Coronary RoadmapPhilips Medical Systems Nederland B.V.20171—
+3K151598VesselNavigator Rel. 1.0Philips Medical Systems Nederland B.V.20158—
+3K142273EmboGuidePhilips Medical Systems Nederland B.V.20151—
+3K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+3K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+3K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+4K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.20260—
+4K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+4K172307Dynamic Coronary Roadmap 2.0Philips Medical Systems Nederland B.V.20170—
+4K160088Cydar EVCydar, Ltd.20167—
+4K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+4K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+4K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+4K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+5K243884TavipilotCaranx Medical20250—
+5K222998F3Acrew Imaging, Inc.20230—
+5K212442Cydar EV (Series B) and Cydar EV MapsCydar, Ltd.20211—
+5K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+5K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+5K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+5K171829EndoNautTherenva Sas20173—
+6K252500CARA SystemCara Medical, Ltd.20260—
+6K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+6K212383EndoNautTherenva Sas20212—
+6K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+7K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+7K222070EndoNautTherenva Sas20221—
+7K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+7K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+8K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PADBrainlab AG20250—
+8K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+8K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+8K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+9K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+9K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+9K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+10K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+10K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+11K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+11K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+11K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+12K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+12K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+12K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+12K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+12K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+12K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+13K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+13K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+13K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+13K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+14K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+14K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+14K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+15K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—