510(k) Report

Devices descending from K002715

271 later devices reach Ecat Pet Scanner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+6K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+6K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+6K220813Art-PlanTherapanacea20224—
+6K213976Contour ProtégéAIMim Software, Inc.20224—
+6K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+6K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20212—
+6K210173StarGuideGE Healthcare20211—
+6K192277CardIQ FlowGE Medical Systems SCS20200—
+6K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20183—
+6K172418OpenSightNovarad Corporation20185—
+6K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc.20180—
+6K162483Symbia Intevo BoldSiemens Medical Solutions USA, Inc.201763—
+6K162337Symbia 6.5Siemens Medical Solutions USA, Inc.201684
+6K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+6K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+6K121213VitreaadvancedVital Images, Inc.201281
+6K121019Optima NM/CT 640GE Healthcare20120Class I
+6K113350Brivo NM 615GE Healthcare20110Class I
+6K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+6K103429Biograph MMRSiemens Medical Solutions USA, Inc.2011211
+6K101550Biograph MCT FamilySiemens Medical Solutions USA, Inc.201038—
+6K052640Gemini RaptorPhilips Medical Systems (Cleveland), Inc.20051236
+7K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+7K251883MIM – LesionID ProMim Software, Inc.20250—
+7K241350Clarify DLGe Medical Systems Israel, Functional Imaging20250—
+7K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—
+7K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A.20243—
+7K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+7K230023ART-PlanTherapanacea Sas20233—
+7K223774Contour ProtégéAIMim Software, Inc.20233—
+7K221796Cyware 4H and Cysart 4HAbys Medical20221—
+7K213128IntraOp VSP Software DeviceXironetic, LLC20221—
+7K220146VisARNovarad Corporation20220—
+7K200474Symbia 6.7Siemens Medical Solutions USA, Inc.202072
+7K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20192—
+7K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+7K172406Ingenuity TFPhilips Medical Systems (Cleveland), Inc.201703
+7K153289HealthmyneHealthmyne, Inc.20160—
+7K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+7K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+7K140651Celesteion, Pca-9000A/2Toshibamedical Systems Corporation201422
+7K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+7K133226Biograph MMRSiemens Medical Solutions USA, Inc.2013201
+7K123599Ingenuity Digital Pet/CTPhilips Healthcare (Cleveland)201345
+7K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+7K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+7K113448Biograph MCT FamilySiemens Medical Solutions USA, Inc.201137—
+7K103483Ingenuity TF Pet/MRPhilips Healthcare (Cleveland)201104
+7K081426Nexstar Liftoff Pet Application Software SuitePhilips Medical Systems (Cleveland), Inc.20080—
+7K081135Gemini CondorPhilips Medical Systems (Cleveland), Inc.2008013
+8K253844AnyScan 3.0 NM Scanner FamilyMediso Medical Imaging Systems, Ltd.20250—
+8K251401PennPET Explorer Positron Emission TomographTrustees of the University of Pennsylvania20250—
+8K243884TavipilotCaranx Medical20250—
+8K243069Lumys (V1)Intradys20250—
+8K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH20252—
+8K241898Symbia SPECT and SPECT/CT SystemsSiemens Healthineers20240—
+8K232479ART-PlanTherapanacea20232—
+8K231765Contour ProtégéAIMim Software, Inc.20232—
+8K232189OrionXRHoth Intelligence, Inc.20230—
+8K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20231—
+8K210880Vereos PET/CTPhilips Medical Systems Nederland B.V.20212—
+8K210557Symbia VA10A FamilySiemens Medical Solutions USA, Inc.20214—
+8K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+8K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+8K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+8K170490Celesteion, PCA-9000A/3Toshibamedical Systems Corporation20171—
+8K163234Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc.201712—
+8K151988Visible Patient SuiteVisible Patient, Sas20154—
+8K142098Signa Pet/MRGe Medical Systems, LLC201466
+8K123737Biograph MCT FamilySiemens Medical Solutions USA, Inc.20133617
+9K253963Cubresa BrainPETCubresa, Inc.20260—
+9K261306AI Contouring (VA10A)Varian Medical Systems20260—
+9K253078ART.1-USSeetreat Pty, Ltd.20260—
+9K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+9K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20260—
+9K250035Contour ProtégéAI+Mim Software, Inc.20251—
+9K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+9K231420Aura 10 PET/CTXeos Medical20230—
+9K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+9K212896Visible Patient SuiteVisible Patient, Sas20213—
+9K212604Symbia VA10A FamilySiemens Medical Solutions USA, Inc.202131
+9K211764Vereos PET/CTPhilips Medical Systems Nederland B.V.20210—
+9K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.20201Class I
+9K183014uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20193—
+9K181646Celesteion, PCA-9000A/3, V6.5Canon Medical Systems Corporation20180—
+9K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+9K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+9K172531Biograph mMR with mMR Angio Transfer OptionSiemens Medical Solutions USA, Inc.20170—
+9K163619Signa Pet/MRGe Medical Systems, LLC201717
+9K151486Biograph mCT and mCT Flow PET/CT ScannersSiemens Medical Solutions USA, Inc.20153411
+9K141971Biograph True Pet/CT Family SoftwareSiemens Medical Solutions USA, Inc.2014037
+10K253270Contour ProtégéAI+Mim Software, Inc.20260—
+10K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+10K253023BIOGRAPH OneSiemens Healthineers AG20260—
+10K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+10K233457RUSHutom, Inc.20240—
+10K231102Symbia Pro.specta VA20A FamilySiemens Medical Solutions USA, Inc.20232—
+10K213709Signa Pet/MRGe Medical Systems, LLC202203
+10K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243