510(k) Report

Devices descending from K892358

137 later devices reach Pegasys Nuclear Medicine Imaging Computer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071195KHBS (Krishnamurthy Hepato-Biliary Software), Model Version 1.5Ani-Kal Ii, LLC20070—
+1K023190E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc.2002104—
+1K993946Pegasys UltraAdac Laboratories200030—
+1K992731E.Cam ComputerSiemens Medical Solutions USA, Inc.19991111
+2K201933ImagenSPECT 3.0Cardiovascular Imaging Technologies20200—
+2K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+2K152503ImagenSPECTCardiovascular Imaging Technologies20161—
+2K142891HepatiqHepatiq, LLC20140—
+2K101279CORRIDOR4DM V2010 Model: V2010Invia201012—
+2K101013Modification to Scintron IVMiegmbh20101—
+2K080961NM Application SuitePhilips Nuclear Medicine, Inc.2008121
+2K063826Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc.200786—
+2K061029Jetstream WorkspaceAdac Laboratories2006261
+2K041166Siemens Enhanced Imaging SystemSiemens Medical Solutions USA, Inc.20048712
+2K040142Ensphere Tempo Jetstream Workspace Cardiology ModuleAdac Laboratories20040—
+2K021669Physician's Desktop ReviewAdac Laboratories20021—
+2K020643EZ-Scope an & EZ-Scope an LiteHealth Policy Resorters Group, LLC20023—
+3K2608794DMInvia, LLC20260—
+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—
+3K111731Molecular Breast Imaging SoftwareGamma Medica-Ideas Incorporated20110—
+3K111336EBW NM 2.0Philips Medical Systems (Cleveland), Inc.20119—
+3K111024Jetpack 2.0Philips Medical Systems (Cleveland), Inc.20110—
+3K101768Mie Scintron Gamma Camera SystemsMiegmbh20100—
+3K082506Symbia, Version 4.0Siemens Medical Solutions USA, Inc.2008839
+3K072567Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc.2007852
+3K072468Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd.2007101
+3K022342EZ-Scope an, EZ-Scope LightAnzai Medical Co., Ltd.20022—
+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—
+4K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+4K151212Ziostation2Qi Imaging, LLC20152—
+4K143664HeartSeeUniversity of Texas Medical School AT Houston20156—
+4K131625Anyscan-S Spect Imaging SystemAbsolute Imaging Solutions20130—
+4K131634SymbiaSiemens Medical Solutions USA, Inc.2013667
+4K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd.20119—
+4K110844Symbia.NetSiemens Medical Solutions USA, Inc.20110—
+4K100619Symbia.Net, Symbia.Net Select Model 10520828, 10520827Siemens Medical Solutions USA, Inc.20101—
+4K093706Proxiscan Model 101Hybridyne Imaging Technologies, Inc.20100—
+4K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa200913Class I
+4K092471Model Sentinella 102General Equipment For Medical Imaging, S.A.20090—
+5K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+5K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.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—
+5K230082Auto SegmentationGe Medical Systems, LLC20231—
+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—
+5K210831OnQ NeuroCortechs Labs, Inc.20213—
+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—
+5K181892Ziostation2Ziosoft, Inc.20181—
+5K173816NM/CT 850, NM/CT 860GE Healthcare20180Class I
+5K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—
+5K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd.20165—
+5K160120D-SPECT Processing and Reviewing WorkstationSpectrum Dynamics, Ltd.20162—
+5K153402Discovery NM/CT 670 CZTGE Healthcare20166Class I
+5K142006Symbia 6.0Siemens Medical Solutions USA, Inc.2014659
+5K111445Discovery NM 630GE Healthcare20112Class I
+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—
+6K250416GBrain MRIGalileo Cds, Inc.20251—
+6K242925MR Contour DLGE Healthcare20250—
+6K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+6K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+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—
+6K212230TruSPECT Radiological Image Processing StationSpectrum Dynamics Medical, Ltd.20211—
+6K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20212—
+6K210173StarGuideGE Healthcare20211—
+6K200315Ziostation2Ziosoft, Inc.20200—