510(k) Report

Devices descending from K913641

414 later devices reach Sophy NXT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972886MirageSegami Corp., Inc.1997413—
+2K053062Cardiarc Spect Imaging Device, Model CQ103-RV2Cardiarc, Ltd.200616—
+2K052430Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp.20057—
+2K050815Xact.Cardiac & Xpress.CardiacUltraspect, Ltd.200514—
+2K041022Neuroq - Pet DPSyntermed, Inc.2004382—
+3K180077NeuroQ 3.8Syntermed20180—
+3K130451Neuroq 3.6Syntermed, Inc.20131—
+3K082368Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect Imaging…Digirad Corp.20081—
+3K081201WBR XPRESS3.CardiacUltraspect, Ltd.20082—
+3K080784WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.BoneUltraspect, Ltd.200813—
+3K072307Quantitative Neuroq 3.0Syntermed, Inc.20082—
+3K070589C!Transphoton Corporation20070—
+3K070542Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsDigirad Corp.20076—
+3K062450D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd.200614—
+3K062393GE Vantage Pet Neuro SoftwareGE Healthcare20063—
+3K061545Scenium 1.1Siemens Molecular Imaging, Ltd.200691—
+3K060816Mim 4.0 (NeuroMimvista Corp.20063501
+3K042863SceniumSiemens Molecular Imaging, Ltd.2004380—
+4K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+4K203142Veuron-Brain-pAbHeuron Co., Ltd.20215—
+4K190379MIM on LinuxMim Software, Inc.201914—
+4K141074Cortex ID SuiteGe Medical Systems, LLC20142—
+4K133654SceniumSiemens Medical Solutions USA, Inc.20143—
+4K121074Scenium 2.0Siemens Medical Solutions USA, Inc.201290—
+4K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd.20119—
+4K103710WBR Xpress PetUltraspect, Ltd.20110—
+4K100838Ergo Imaging SystemDigirad Corp.20102—
+4K091073WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and Scattering CorrectionsUltraspect, Ltd.20091—
+4K083649Cardius 3 X-ActDigirad Corp.20090—
+4K080124Ventri 1.1Ge Medical Systems F.I. Haifa200822
+4K072191Clearvision Nuclear Medicine Imaging SystemGvi Technology Partners20070—
+4K072468Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd.2007101
+4K071964Mim 4.1 (Seastar)Mimvista Corp.20072872
+4K062163MimviewerMimvista Corp.2006166—
+5K231576cNeuro cPETCombinostics OY20231—
+5K223800MIM – Additional TracersMim Software, Inc.20231—
+5K220256MIM-AblationMim Software, Inc.20224—
+5K221405Neurophet SCALE PETNeurophet., Inc.20222—
+5K213801Veuron-Brain-pAb2Heuron Co., Ltd.20221—
+5K212004MyoSPECT, MyoSpect ESGE Healthcare202101
+5K202700ART-PlanTherapanacea20215—
+5K193252Contour ProtegeAIMim Software, Inc.20206—
+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—
+5K123408Ergo Imaging SystemDigirad Corp.20130—
+5K123528SceniumSiemens Medical Solutions USA, Inc.201279—
+5K111332Clarity Obp SystemElekta, Ltd.20122—
+5K110384Dilon 6800 Acella (Acella)Dilon Technologies, Inc.20110—
+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—
+5K083504GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa200801
+5K081076Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC2008631
+5K070606Visio+CD Viewer# KPSCDVE01Keosys Sas20074—
+5K070248VelocityaisVelocity Medical Solutions, LLC200765—
+6K261916NeuroQuant PETCortechs Labs, Inc.20260—
+6K252563Neurophet SCALE PETNeurophet., Inc.20260—
+6K252496Neurophet AQUA AD PlusNeurophet., Inc.20261—
+6K251363ProKnow DSElekta Solutions AB20250—
+6K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+6K232514MIM – Dose AnalysisMim Software, Inc.20240—
+6K233572AutofusePymedix20240—
+6K231642Veuron-Brain-pAb3Heuron Co., Ltd.20230—
+6K220813Art-PlanTherapanacea20224—
+6K220779XDMirada Medical, Ltd.20220—
+6K210632Contour ProtegeAIMim Software, Inc.20215—
+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
+6K140269Hermes Medical Imaging Suite V5.4Hermes Medical Solutions AB201415—
+6K123082Mobilect ViewerNephosity, Inc.20130—
+6K130884Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa201377—
+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—