510(k) Report

Devices descending from K040254

84 later devices reach Integris 3D-RA, Release 4.2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121772Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1Philips Medical Systems Nederland B.V.201315—
+1K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+1K110256The IC-Pro SystemPaieon, Inc.201115—
+1K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+1K062650EP Navigator SoftwarePhilips Medical Systems200649—
+1K042334Allura 3D-CA, Release 1Philips Medical Systems North America Co.200451—
+2K201583SmartCT R1.0Philips Medical Systems Nederland B.V.20211—
+2K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+2K170130Dynamic Coronary RoadmapPhilips Medical Systems Nederland B.V.20171—
+2K163622Lung VisionBodyvision Medical, Ltd.20176—
+2K160147CT TrueViewPhilips Medical Systems Nederland B.V.20160—
+2K151598VesselNavigator Rel. 1.0Philips Medical Systems Nederland B.V.20158—
+2K142273EmboGuidePhilips Medical Systems Nederland B.V.20151—
+2K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+2K133993Caas WorkstationPie Medical Imaging201410—
+2K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+2K120282CardnavPaieon, Inc.20120—
+2K113594C-THV SystemPaieon, Inc.20120—
+2K113076Caas a-ValvePie Medical Imaging BV20121—
+2K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+3K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.20260—
+3K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+3K172418OpenSightNovarad Corporation20185—
+3K172307Dynamic Coronary Roadmap 2.0Philips Medical Systems Nederland B.V.20170—
+3K160088Cydar EVCydar, Ltd.20167—
+3K151780CAAS WorkstationPie Medical Imaging BV20169—
+3K143044CAAS A-ValvePie Medical Imaging BV20150—
+3K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+3K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+3K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+4K243884TavipilotCaranx Medical20250—
+4K222998F3Acrew Imaging, Inc.20230—
+4K221796Cyware 4H and Cysart 4HAbys Medical20221—
+4K213128IntraOp VSP Software DeviceXironetic, LLC20221—
+4K220146VisARNovarad Corporation20220—
+4K212442Cydar EV (Series B) and Cydar EV MapsCydar, Ltd.20211—
+4K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+4K180019CAAS WorkstationPie Medical Imaging BV20188—
+4K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+4K171829EndoNautTherenva Sas20173—
+5K252500CARA SystemCara Medical, Ltd.20260—
+5K251355X1-FFRSpectrawave, Inc.20250—
+5K243069Lumys (V1)Intradys20250—
+5K232147CAAS WorkstationPie Medical Imaging BV20241—
+5K232189OrionXRHoth Intelligence, Inc.20230—
+5K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+5K212383EndoNautTherenva Sas20212—
+5K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+5K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+6K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+6K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+6K243769QFR (3.0)Qfr Solutions BV20250—
+6K222070EndoNautTherenva Sas20221—
+6K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+6K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+6K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+7K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PADBrainlab AG20250—
+7K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+7K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+7K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+7K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+7K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+8K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+8K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+8K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+9K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+9K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+10K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+10K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+10K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+11K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+11K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+11K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+11K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+11K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+11K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+12K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+12K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+12K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+12K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+13K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+13K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+13K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+14K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—