510(k) Report

Devices descending from K042646

72 later devices reach Dynact through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073259Xidf-100A/B1 Image ProcessorToshiba America Medical Systems, In.C20070—
+1K061685PulseraPhilips Medical Systems North America Co.200615—
+1K060749XperctPhilips Medical Systems North America Co.200653—
+1K052157Innova CT Option for Digital Fluoroscopic Imaging Systems Innova Models 4100, 4100IQ…Ge Medical Systems, LLC2005039
+2K130893Xperct Rel. 3Philips Medical Systems Nederland B.V.20132—
+2K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+2K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+2K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+2K090590Veradius, Model 718-130Philips Medical Systems North America Co.200914—
+2K062650EP Navigator SoftwarePhilips Medical Systems200649—
+3K201583SmartCT R1.0Philips Medical Systems Nederland B.V.20211—
+3K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+3K163622Lung VisionBodyvision Medical, Ltd.20176—
+3K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+3K133819VeradiusPhilips Medical Systems Nederland B.V.201412—
+3K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+3K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+3K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+3K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+3K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+4K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.20260—
+4K243884TavipilotCaranx Medical20250—
+4K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+4K172418OpenSightNovarad Corporation20185—
+4K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+4K142708Veradius UnityPhilips Medical Systems Nethrlands BV2014114
+5K250010Extron 3; Extron 5; Extron 7DRTECH Corporation20251—
+5K230871Extron 5; Extron 7DRTECH Corporation20233—
+5K221796Cyware 4H and Cysart 4HAbys Medical20221—
+5K213128IntraOp VSP Software DeviceXironetic, LLC20221—
+5K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+5K220146VisARNovarad Corporation20220—
+5K183040Zenition 70Philips Medical Systems Nederland B.V.201865
+5K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+6K261413Extron 3;Extron 6DRTECH Corporation20260—
+6K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+6K251893Skan C PulsarSkanray Technologies Limited20250—
+6K243069Lumys (V1)Intradys20250—
+6K232189OrionXRHoth Intelligence, Inc.20230—
+6K222080Garion Image-Intensified Fluoroscopic X-Ray System, MobileSg Healthcare Co, Ltd.20221—
+6K212813Zenition 70Philips Medical Systems Nederland B.V.202134
+6K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+6K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+7K243411Diagnostic X-ray SystemNanjing Perlove Medical Equipment Co., Ltd.20250—
+7K240224Zenition 90Philips Medical Systems Nederlands B.V.20240—
+7K232420Zenition 30Philips Medical Systems Nederland B.V.20241—
+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
+8K254205Zenition 30Philips Medical Systems Nederland B.V.20260—
+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—