510(k) Report

Devices descending from K982855

381 later devices reach Digirad 2020TC Spect Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100838Ergo Imaging SystemDigirad Corp.20102—
+1K082368Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect Imaging…Digirad Corp.20081—
+1K070542Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsDigirad Corp.20076—
+1K053062Cardiarc Spect Imaging Device, Model CQ103-RV2Cardiarc, Ltd.200616—
+1K052430Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp.20057—
+1K051549Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp.20058—
+1K011572Quantitative Gated Spect (QGS), Quantitative Perfusion Spect (QPS)Digirad Corp.2001354—
+2K123408Ergo Imaging SystemDigirad Corp.20130—
+2K110384Dilon 6800 Acella (Acella)Dilon Technologies, Inc.20110—
+2K083649Cardius 3 X-ActDigirad Corp.20090—
+2K072191Clearvision Nuclear Medicine Imaging SystemGvi Technology Partners20070—
+2K070589C!Transphoton Corporation20070—
+2K062450D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd.200614—
+2K052379Mim 3.5 (Circa)Mimvista Corp.2005353—
+3K190379MIM on LinuxMim Software, Inc.201914—
+3K170841BiopSee, Mobile USMedcom GmbH20170—
+3K163119NaviSuite SSI EditionMedcom GmbH20171—
+3K080124Ventri 1.1Ge Medical Systems F.I. Haifa200822
+3K072468Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd.2007101
+3K060816Mim 4.0 (NeuroMimvista Corp.20063501
+4K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+4K223800MIM – Additional TracersMim Software, Inc.20231—
+4K220256MIM-AblationMim Software, Inc.20224—
+4K212004MyoSPECT, MyoSpect ESGE Healthcare202101
+4K203142Veuron-Brain-pAbHeuron Co., Ltd.20215—
+4K193252Contour ProtegeAIMim Software, Inc.20206—
+4K133654SceniumSiemens Medical Solutions USA, Inc.20143—
+4K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd.20119—
+4K083504GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa200801
+4K071964Mim 4.1 (Seastar)Mimvista Corp.20072872
+4K062163MimviewerMimvista Corp.2006166—
+5K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+5K232514MIM – Dose AnalysisMim Software, Inc.20240—
+5K221405Neurophet SCALE PETNeurophet., Inc.20222—
+5K213801Veuron-Brain-pAb2Heuron Co., Ltd.20221—
+5K210632Contour ProtegeAIMim Software, Inc.20215—
+5K202700ART-PlanTherapanacea20215—
+5K182855ProKnow DSProknow, LLC20192—
+5K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd.20165—
+5K160120D-SPECT Processing and Reviewing WorkstationSpectrum Dynamics, Ltd.20162—
+5K150192SceniumSiemens Medical Solutions USA, Inc.20152—
+5K120851Communify Pacs ViewerCommunify Health, LLC20130—
+5K111332Clarity Obp SystemElekta, Ltd.20122—
+5K103576Mim 5.2 (Brachy)Mim Software, Inc.201179—
+5K103785Mobile MimMim Software, Inc.2011120—
+5K101707Fulaccess Model 1.0Fulcrum Medical, Inc.20103—
+5K101228Mirada XDMirada Medical, Ltd.201070—
+5K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+5K081076Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC2008631
+5K070606Visio+CD Viewer# KPSCDVE01Keosys Sas20074—
+5K070248VelocityaisVelocity Medical Solutions, LLC200765—
+6K252563Neurophet SCALE PETNeurophet., Inc.20260—
+6K252496Neurophet AQUA AD PlusNeurophet., Inc.20261—
+6K251363ProKnow DSElekta Solutions AB20250—
+6K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+6K233572AutofusePymedix20240—
+6K231642Veuron-Brain-pAb3Heuron Co., Ltd.20230—
+6K220813Art-PlanTherapanacea20224—
+6K220779XDMirada Medical, Ltd.20220—
+6K213976Contour ProtégéAIMim Software, Inc.20224—
+6K212230TruSPECT Radiological Image Processing StationSpectrum Dynamics Medical, Ltd.20211—
+6K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—
+6K180522IGTFusionIgi Technologies20180—
+6K180514Veriton NMSpectrum Dynamics Medical, Ltd.20184—
+6K180129Imbio Segmentation Editing Tool softwareImbio, LLC20180—
+6K173636VelocityVarian Medical Systems, Inc.20188—
+6K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+6K173420Radiomics App v1.0Microsoft Corp.20174—
+6K172218MIM – Y90 DosimetryMim Software, Inc.201767—
+6K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+6K160371NovaPACSNovarad Corporation20165—
+6K162339SceniumSiemens Medical Solutions USA, Inc.20161—
+6K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+6K153014Mobius3DMobius Medical Systems, LP201613—
+6K151913MIM-Thin Client (mobile)Mim Software, Inc.201668—
+6K143514Panther StereoSeedProwess, Inc.20150—
+6K143397ICIS ViewAgfa Healthcare N.V.20156—
+6K132853NovapacsNovarad Corp.201462
+6K123082Mobilect ViewerNephosity, Inc.20130—
+6K130393Mirada RTXMirada Medical, Ltd.201336—
+6K123357Onq RTSOncology Systems, Inc.20120—
+6K121663ClarityElekta, Ltd.20121—
+6K122260Aycan MobileAycan Digitalsysteme GmbH20120—
+6K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+6K112930Mobile MimMim Software, Inc.201199—
+6K111694ASTRACandelis, Inc.20115—
+6K102000ImagysKeosys Sas20103—
+6K102687Mirada RTMirada Medical, Ltd.201037—
+6K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+6K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+6K080325IGROKIgrok, LLC20080—
+7K253532TruSPECT Processing StationSpectrum Dynamics Medical, Ltd.20250—
+7K251883MIM – LesionID ProMim Software, Inc.20250—
+7K231662Aid-UIaid20241—
+7K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+7K230023ART-PlanTherapanacea Sas20233—
+7K223774Contour ProtégéAIMim Software, Inc.20233—
+7K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+7K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+7K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—