510(k) Report

Devices descending from K041955

65 later devices reach Gemini Pet/CT Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062650EP Navigator SoftwarePhilips Medical Systems200649—
+1K042935Gemini GXLPhilips Medical Systems (Cleveland), Inc.2004142
+2K163622Lung VisionBodyvision Medical, Ltd.20176—
+2K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+2K051170Gemini GXLPhilips Medical Systems (Cleveland), Inc.20051312
+3K172418OpenSightNovarad Corporation20185—
+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—
+3K052640Gemini RaptorPhilips Medical Systems (Cleveland), Inc.20051236
+4K221796Cyware 4H and Cysart 4HAbys Medical20221—
+4K213128IntraOp VSP Software DeviceXironetic, LLC20221—
+4K220146VisARNovarad Corporation20220—
+4K172406Ingenuity TFPhilips Medical Systems (Cleveland), Inc.201703
+4K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+4K140651Celesteion, Pca-9000A/2Toshibamedical Systems Corporation201422
+4K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+4K123599Ingenuity Digital Pet/CTPhilips Healthcare (Cleveland)201345
+4K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+4K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+4K103483Ingenuity TF Pet/MRPhilips Healthcare (Cleveland)201104
+4K081426Nexstar Liftoff Pet Application Software SuitePhilips Medical Systems (Cleveland), Inc.20080—
+4K081135Gemini CondorPhilips Medical Systems (Cleveland), Inc.2008013
+5K251401PennPET Explorer Positron Emission TomographTrustees of the University of Pennsylvania20250—
+5K243884TavipilotCaranx Medical20250—
+5K243069Lumys (V1)Intradys20250—
+5K232189OrionXRHoth Intelligence, Inc.20230—
+5K210880Vereos PET/CTPhilips Medical Systems Nederland B.V.20212—
+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
+5K170490Celesteion, PCA-9000A/3Toshibamedical Systems Corporation20171—
+6K231420Aura 10 PET/CTXeos Medical20230—
+6K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+6K211764Vereos PET/CTPhilips Medical Systems Nederland B.V.20210—
+6K181646Celesteion, PCA-9000A/3, V6.5Canon Medical Systems Corporation20180—
+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—
+7K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+7K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+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—