510(k) Report

Devices descending from K952109

115 later devices reach IP500 Nuclear Gamma Camera System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082506Symbia, Version 4.0Siemens Medical Solutions USA, Inc.2008839
+1K041166Siemens Enhanced Imaging SystemSiemens Medical Solutions USA, Inc.20048712
+1K992731E.Cam ComputerSiemens Medical Solutions USA, Inc.19991111
+1K981027E.Cam Lso 311 Pet/Spect SystemCti Pet Systems, Inc.19982—
+2K131634SymbiaSiemens Medical Solutions USA, Inc.2013667
+2K110844Symbia.NetSiemens Medical Solutions USA, Inc.20110—
+2K100619Symbia.Net, Symbia.Net Select Model 10520828, 10520827Siemens Medical Solutions USA, Inc.20101—
+2K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa200913Class I
+2K072567Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc.2007852
+2K071195KHBS (Krishnamurthy Hepato-Biliary Software), Model Version 1.5Ani-Kal Ii, LLC20070—
+2K063826Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc.200786—
+2K040933Ecat HRRTCti Pet Systems, Inc.20040—
+2K023190E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc.2002104—
+2K021633Ecat Vision Pet Scanner, Models 3000 & 5000Cti Pet Systems, Inc.20020—
+2K020643EZ-Scope an & EZ-Scope an LiteHealth Policy Resorters Group, LLC20023—
+3K243605AuroraGe Medical Systems Israel, Functional Imaging20251—
+3K201933ImagenSPECT 3.0Cardiovascular Imaging Technologies20200—
+3K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+3K173816NM/CT 850, NM/CT 860GE Healthcare20180Class I
+3K152503ImagenSPECTCardiovascular Imaging Technologies20161—
+3K153402Discovery NM/CT 670 CZTGE Healthcare20166Class I
+3K142006Symbia 6.0Siemens Medical Solutions USA, Inc.2014659
+3K131625Anyscan-S Spect Imaging SystemAbsolute Imaging Solutions20130—
+3K111445Discovery NM 630GE Healthcare20112Class I
+3K101279CORRIDOR4DM V2010 Model: V2010Invia201012—
+3K101013Modification to Scintron IVMiegmbh20101—
+3K022342EZ-Scope an, EZ-Scope LightAnzai Medical Co., Ltd.20022—
+4K2608794DMInvia, LLC20260—
+4K251153AuroraGe Medical Systems Israel20250—
+4K210173StarGuideGE Healthcare20211—
+4K190379MIM on LinuxMim Software, Inc.201914—
+4K182624MIM - MRT DosimetryMim Software, Inc.201853—
+4K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20183—
+4K173512MFI-CardiacMultifunctional Imaging, LLC20180—
+4K162483Symbia Intevo BoldSiemens Medical Solutions USA, Inc.201763—
+4K162337Symbia 6.5Siemens Medical Solutions USA, Inc.201684
+4K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+4K113754CFR QuantUniversity of Texas Medical School AT Houston20129—
+4K121019Optima NM/CT 640GE Healthcare20120Class I
+4K113350Brivo NM 615GE Healthcare20110Class I
+4K101768Mie Scintron Gamma Camera SystemsMiegmbh20100—
+4K093706Proxiscan Model 101Hybridyne Imaging Technologies, Inc.20100—
+4K092471Model Sentinella 102General Equipment For Medical Imaging, S.A.20090—
+5K241350Clarify DLGe Medical Systems Israel, Functional Imaging20250—
+5K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+5K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+5K223800MIM – Additional TracersMim Software, Inc.20231—
+5K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+5K220256MIM-AblationMim Software, Inc.20224—
+5K203235VBrainVysioneer, Inc.20214—
+5K193252Contour ProtegeAIMim Software, Inc.20206—
+5K200474Symbia 6.7Siemens Medical Solutions USA, Inc.202072
+5K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+5K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+5K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20192—
+5K143664HeartSeeUniversity of Texas Medical School AT Houston20156—
+6K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+6K253844AnyScan 3.0 NM Scanner FamilyMediso Medical Imaging Systems, Ltd.20250—
+6K252922Neosoma Brain MetsNeosoma, Inc.20250—
+6K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+6K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+6K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+6K241898Symbia SPECT and SPECT/CT SystemsSiemens Healthineers20240—
+6K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+6K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+6K232514MIM – Dose AnalysisMim Software, Inc.20240—
+6K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+6K230082Auto SegmentationGe Medical Systems, LLC20231—
+6K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20231—
+6K221706AccuContourManteia Technologies Co., Ltd.20232—
+6K220630TorchTM SoftwareVoximetry, Incorporated20221—
+6K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+6K213628VBrainVysioneer, Inc.20210—
+6K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+6K210632Contour ProtegeAIMim Software, Inc.20215—
+6K212116VBrain-OARVysioneer, Inc.20211—
+6K210557Symbia VA10A FamilySiemens Medical Solutions USA, Inc.20214—
+6K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+6K202700ART-PlanTherapanacea20215—
+6K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+6K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—
+7K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+7K253835AffinityHermes Medical Solutions AB20260—
+7K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+7K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20260—
+7K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+7K242925MR Contour DLGE Healthcare20250—
+7K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+7K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+7K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+7K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+7K220813Art-PlanTherapanacea20224—
+7K213976Contour ProtégéAIMim Software, Inc.20224—
+7K212604Symbia VA10A FamilySiemens Medical Solutions USA, Inc.202131
+7K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20212—
+7K192277CardIQ FlowGE Medical Systems SCS20200—
+7K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc.20180—
+8K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+8K251883MIM – LesionID ProMim Software, Inc.20250—
+8K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—