510(k) Report

Devices descending from K952674

125 later devices reach Transact: Attenuation Correction System for the Apex Cardial Gamma Camera through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982300Transview (Transmission System),Model NDTR-701AToshiba America Medical Systems, In.C19980—
+1K980959Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa1998123—
+2K994167Code AC: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera with…Ge Medical Systems F.I. Haifa20000—
+2K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa1999120Class I
+2K991896MG Atc: Attenuation Correction System for Dual-Head Variable-Angle Gamma CameraGe Medical Systems F.I. Haifa19990—
+3K071195KHBS (Krishnamurthy Hepato-Biliary Software), Model Version 1.5Ani-Kal Ii, LLC20070—
+3K052434Hawkeye 4 Option for Dual-Head Variable Angle Gamma CameraGE Medical Systems200516Class I
+3K043381Infinia LightspeedGe Medical Systems F.I. Haifa20041—
+3K041166Siemens Enhanced Imaging SystemSiemens Medical Solutions USA, Inc.20048712
+3K023190E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc.2002104—
+3K022960GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa200223Class I
+4K201933ImagenSPECT 3.0Cardiovascular Imaging Technologies20200—
+4K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+4K152503ImagenSPECTCardiovascular Imaging Technologies20161—
+4K121019Optima NM/CT 640GE Healthcare20120Class I
+4K102231Discovery NM 750BGe Medical Systems Israel, Functional Imaging20103—
+4K101279CORRIDOR4DM V2010 Model: V2010Invia201012—
+4K101013Modification to Scintron IVMiegmbh20101—
+4K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa200913Class I
+4K083504GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa200801
+4K082506Symbia, Version 4.0Siemens Medical Solutions USA, Inc.2008839
+4K080927Brightview VCT Imaging SystemPhilips Medical Systems (Cleveland), Inc.20081Class I
+4K072567Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc.2007852
+4K063826Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc.200786—
+4K051855VentriGe Medical Systems F.I. Haifa200533
+5K2608794DMInvia, LLC20260—
+5K243605AuroraGe Medical Systems Israel, Functional Imaging20251—
+5K190379MIM on LinuxMim Software, Inc.201914—
+5K182624MIM - MRT DosimetryMim Software, Inc.201853—
+5K173816NM/CT 850, NM/CT 860GE Healthcare20180Class I
+5K173512MFI-CardiacMultifunctional Imaging, LLC20180—
+5K160933Discovery NM 750b BopsyGE Healthcare20160—
+5K153402Discovery NM/CT 670 CZTGE Healthcare20166Class I
+5K131625Anyscan-S Spect Imaging SystemAbsolute Imaging Solutions20130—
+5K131634SymbiaSiemens Medical Solutions USA, Inc.2013667
+5K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+5K113754CFR QuantUniversity of Texas Medical School AT Houston20129—
+5K111791Lumagem Molecular Breast Imaging SystemGamma Medica-Ideas Incorporated20111—
+5K111445Discovery NM 630GE Healthcare20112Class I
+5K110844Symbia.NetSiemens Medical Solutions USA, Inc.20110—
+5K101768Mie Scintron Gamma Camera SystemsMiegmbh20100—
+5K100619Symbia.Net, Symbia.Net Select Model 10520828, 10520827Siemens Medical Solutions USA, Inc.20101—
+5K083649Cardius 3 X-ActDigirad Corp.20090—
+5K080124Ventri 1.1Ge Medical Systems F.I. Haifa200822
+6K251153AuroraGe Medical Systems Israel20250—
+6K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+6K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+6K223800MIM – Additional TracersMim Software, Inc.20231—
+6K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+6K220256MIM-AblationMim Software, Inc.20224—
+6K212004MyoSPECT, MyoSpect ESGE Healthcare202101
+6K210173StarGuideGE Healthcare20211—
+6K203235VBrainVysioneer, Inc.20214—
+6K193252Contour ProtegeAIMim Software, Inc.20206—
+6K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+6K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+6K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20183—
+6K143664HeartSeeUniversity of Texas Medical School AT Houston20156—
+6K142006Symbia 6.0Siemens Medical Solutions USA, Inc.2014659
+6K123408Ergo Imaging SystemDigirad Corp.20130—
+6K113350Brivo NM 615GE Healthcare20110Class I
+7K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+7K252922Neosoma Brain MetsNeosoma, Inc.20250—
+7K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+7K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+7K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+7K241350Clarify DLGe Medical Systems Israel, Functional Imaging20250—
+7K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+7K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+7K232514MIM – Dose AnalysisMim Software, Inc.20240—
+7K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+7K230082Auto SegmentationGe Medical Systems, LLC20231—
+7K221706AccuContourManteia Technologies Co., Ltd.20232—
+7K220630TorchTM SoftwareVoximetry, Incorporated20221—
+7K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+7K213628VBrainVysioneer, Inc.20210—
+7K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+7K210632Contour ProtegeAIMim Software, Inc.20215—
+7K212116VBrain-OARVysioneer, Inc.20211—
+7K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+7K202700ART-PlanTherapanacea20215—
+7K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+7K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20192—
+7K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—
+7K162483Symbia Intevo BoldSiemens Medical Solutions USA, Inc.201763—
+7K162337Symbia 6.5Siemens Medical Solutions USA, Inc.201684
+8K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+8K253835AffinityHermes Medical Solutions AB20260—
+8K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+8K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+8K242925MR Contour DLGE Healthcare20250—
+8K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+8K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+8K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+8K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20231—
+8K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+8K220813Art-PlanTherapanacea20224—
+8K213976Contour ProtégéAIMim Software, Inc.20224—
+8K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20212—
+8K200474Symbia 6.7Siemens Medical Solutions USA, Inc.202072