510(k) Report

Devices descending from K002715

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032063Pem 2400 Pet ScannerPem Technologies200322
+1K023768Ecat Pet/CT; Ecat Lso Pet/CT; Ecat Lso Pet/CT 16Cti Pet Systems, Inc.20021—
+1K023190E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc.2002104—
+1K021633Ecat Vision Pet Scanner, Models 3000 & 5000Cti Pet Systems, Inc.20020—
+1K013521Gemini Imaging SystemAdac Laboratories2001882
+1K013504Modification to: Ecat Lso Pet/CT ScannerCti Pet Systems, Inc.2001732
+2K201807AncorisMiegmbh20200—
+2K201933ImagenSPECT 3.0Cardiovascular Imaging Technologies20200—
+2K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+2K152503ImagenSPECTCardiovascular Imaging Technologies20161—
+2K101279CORRIDOR4DM V2010 Model: V2010Invia201012—
+2K101013Modification to Scintron IVMiegmbh20101—
+2K090553Naviscan Pemflex Solo II High Resolution Pet ScannerNaviscan, Inc.20091—
+2K063826Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc.200786—
+2K042428SCEPTREP3 Pet/CTHitachi Medical Systems America, Inc.200402
+2K033431Lso Pet/CT Hirez and Lso Pet/CT 16 HirezCti Pet Systems, Inc.2003681
+2K032036Gemini 16Philips Medical Systems (Cleveland), Inc.2003872
+2K023518Ecat Lso Pet/CT 16Cti Pet Systems, Inc.2002711
+3K2608794DMInvia, LLC20260—
+3K214062Radialis PET CameraRadialis, Inc.20220—
+3K190379MIM on LinuxMim Software, Inc.201914—
+3K182624MIM - MRT DosimetryMim Software, Inc.201853—
+3K173512MFI-CardiacMultifunctional Imaging, LLC20180—
+3K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+3K113754CFR QuantUniversity of Texas Medical School AT Houston20129—
+3K101768Mie Scintron Gamma Camera SystemsMiegmbh20100—
+3K082506Symbia, Version 4.0Siemens Medical Solutions USA, Inc.2008839
+3K072567Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc.2007852
+3K050509Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64ICti Pet Systems, Inc.200566—
+3K042467Lso Pet/CT Hirez 64Cti Pet Systems, Inc.2004671
+3K041955Gemini Pet/CT Imaging SystemPhilips Medical Systems (Cleveland), Inc.2004652
+3K041182SyntegraAdac Laboratories200420—
+4K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+4K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+4K223800MIM – Additional TracersMim Software, Inc.20231—
+4K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+4K220256MIM-AblationMim Software, Inc.20224—
+4K203235VBrainVysioneer, Inc.20214—
+4K193252Contour ProtegeAIMim Software, Inc.20206—
+4K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+4K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+4K143664HeartSeeUniversity of Texas Medical School AT Houston20156—
+4K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+4K131625Anyscan-S Spect Imaging SystemAbsolute Imaging Solutions20130—
+4K131634SymbiaSiemens Medical Solutions USA, Inc.2013667
+4K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+4K110844Symbia.NetSiemens Medical Solutions USA, Inc.20110—
+4K100619Symbia.Net, Symbia.Net Select Model 10520828, 10520827Siemens Medical Solutions USA, Inc.20101—
+4K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa200913Class I
+4K081987Unisyn Image Fusion, Version 1.0Convergent Imaging Solutions20087—
+4K062650EP Navigator SoftwarePhilips Medical Systems200649—
+4K061671Syngo Trued, Model VC10ASiemens Medical Solutions200611—
+4K060631Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc.2006643
+4K060060Biograph 6Siemens Medical Solutions USA, Inc.200665—
+4K042935Gemini GXLPhilips Medical Systems (Cleveland), Inc.2004142
+5K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+5K252922Neosoma Brain MetsNeosoma, Inc.20250—
+5K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+5K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+5K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+5K243605AuroraGe Medical Systems Israel, Functional Imaging20251—
+5K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+5K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+5K232514MIM – Dose AnalysisMim Software, Inc.20240—
+5K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+5K231047UniSyn Molecular Imaging (6-3-1)Convergent Imaging Solutions20230—
+5K230082Auto SegmentationGe Medical Systems, LLC20231—
+5K230393UniCam Evo SoftwareInter Medical Medizintechnik GmbH20230—
+5K221706AccuContourManteia Technologies Co., Ltd.20232—
+5K220630TorchTM SoftwareVoximetry, Incorporated20221—
+5K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+5K213628VBrainVysioneer, Inc.20210—
+5K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+5K210632Contour ProtegeAIMim Software, Inc.20215—
+5K212116VBrain-OARVysioneer, Inc.20211—
+5K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+5K202700ART-PlanTherapanacea20215—
+5K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+5K173816NM/CT 850, NM/CT 860GE Healthcare20180Class I
+5K173547ImagenUniversalCardiovascular Imaging Technologies20180—
+5K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—
+5K163622Lung VisionBodyvision Medical, Ltd.20176—
+5K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+5K153402Discovery NM/CT 670 CZTGE Healthcare20166Class I
+5K142006Symbia 6.0Siemens Medical Solutions USA, Inc.2014659
+5K111445Discovery NM 630GE Healthcare20112Class I
+5K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+5K083852Biograph 16 True Point SystemsSiemens Medical Solutions USA, Inc.20090—
+5K081792Spy Analysis Toolkit, Model SA9000Novadaq Technologies, Inc.20080—
+5K081453Biograph HD FamilySiemens Medical Solutions USA, Inc.200862—
+5K071241LMS-LiverMedian Technologies20079—
+5K071068Biograph 6 Truepoint, Model Biograph 6 - P/N 10238197Siemens Medical Solutions USA, Inc.20070—
+5K051170Gemini GXLPhilips Medical Systems (Cleveland), Inc.20051312
+6K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+6K253835AffinityHermes Medical Solutions AB20260—
+6K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+6K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+6K251153AuroraGe Medical Systems Israel20250—
+6K242925MR Contour DLGE Healthcare20250—
+6K241765PLANET Onco Dose (3.2)Dosisoft SA20250—