510(k) Report

Devices descending from K011572

354 later devices reach Quantitative Gated Spect (QGS), Quantitative Perfusion Spect (QPS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052379Mim 3.5 (Circa)Mimvista Corp.2005353—
+2K190379MIM on LinuxMim Software, Inc.201914—
+2K170841BiopSee, Mobile USMedcom GmbH20170—
+2K163119NaviSuite SSI EditionMedcom GmbH20171—
+2K060816Mim 4.0 (NeuroMimvista Corp.20063501
+3K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+3K223800MIM – Additional TracersMim Software, Inc.20231—
+3K220256MIM-AblationMim Software, Inc.20224—
+3K203142Veuron-Brain-pAbHeuron Co., Ltd.20215—
+3K193252Contour ProtegeAIMim Software, Inc.20206—
+3K133654SceniumSiemens Medical Solutions USA, Inc.20143—
+3K071964Mim 4.1 (Seastar)Mimvista Corp.20072872
+3K062163MimviewerMimvista Corp.2006166—
+4K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+4K232514MIM – Dose AnalysisMim Software, Inc.20240—
+4K221405Neurophet SCALE PETNeurophet., Inc.20222—
+4K213801Veuron-Brain-pAb2Heuron Co., Ltd.20221—
+4K210632Contour ProtegeAIMim Software, Inc.20215—
+4K202700ART-PlanTherapanacea20215—
+4K182855ProKnow DSProknow, LLC20192—
+4K150192SceniumSiemens Medical Solutions USA, Inc.20152—
+4K120851Communify Pacs ViewerCommunify Health, LLC20130—
+4K111332Clarity Obp SystemElekta, Ltd.20122—
+4K103576Mim 5.2 (Brachy)Mim Software, Inc.201179—
+4K103785Mobile MimMim Software, Inc.2011120—
+4K101707Fulaccess Model 1.0Fulcrum Medical, Inc.20103—
+4K101228Mirada XDMirada Medical, Ltd.201070—
+4K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+4K081076Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC2008631
+4K070606Visio+CD Viewer# KPSCDVE01Keosys Sas20074—
+4K070248VelocityaisVelocity Medical Solutions, LLC200765—
+5K252563Neurophet SCALE PETNeurophet., Inc.20260—
+5K252496Neurophet AQUA AD PlusNeurophet., Inc.20261—
+5K251363ProKnow DSElekta Solutions AB20250—
+5K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+5K233572AutofusePymedix20240—
+5K231642Veuron-Brain-pAb3Heuron Co., Ltd.20230—
+5K220813Art-PlanTherapanacea20224—
+5K220779XDMirada Medical, Ltd.20220—
+5K213976Contour ProtégéAIMim Software, Inc.20224—
+5K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—
+5K180522IGTFusionIgi Technologies20180—
+5K180129Imbio Segmentation Editing Tool softwareImbio, LLC20180—
+5K173636VelocityVarian Medical Systems, Inc.20188—
+5K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+5K173420Radiomics App v1.0Microsoft Corp.20174—
+5K172218MIM – Y90 DosimetryMim Software, Inc.201767—
+5K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+5K160371NovaPACSNovarad Corporation20165—
+5K162339SceniumSiemens Medical Solutions USA, Inc.20161—
+5K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+5K153014Mobius3DMobius Medical Systems, LP201613—
+5K151913MIM-Thin Client (mobile)Mim Software, Inc.201668—
+5K143514Panther StereoSeedProwess, Inc.20150—
+5K143397ICIS ViewAgfa Healthcare N.V.20156—
+5K132853NovapacsNovarad Corp.201462
+5K123082Mobilect ViewerNephosity, Inc.20130—
+5K130393Mirada RTXMirada Medical, Ltd.201336—
+5K123357Onq RTSOncology Systems, Inc.20120—
+5K121663ClarityElekta, Ltd.20121—
+5K122260Aycan MobileAycan Digitalsysteme GmbH20120—
+5K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+5K112930Mobile MimMim Software, Inc.201199—
+5K111694ASTRACandelis, Inc.20115—
+5K102000ImagysKeosys Sas20103—
+5K102687Mirada RTMirada Medical, Ltd.201037—
+5K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+5K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+5K080325IGROKIgrok, LLC20080—
+6K251883MIM – LesionID ProMim Software, Inc.20250—
+6K231662Aid-UIaid20241—
+6K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+6K230023ART-PlanTherapanacea Sas20233—
+6K223774Contour ProtégéAIMim Software, Inc.20233—
+6K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+6K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+6K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—
+6K211655aPROMISEExini Diagnostics AB20211—
+6K200323AutoContourRadformation, Inc.20207—
+6K201232Limbus ContourLimbus Ai, Inc.20202—
+6K201798myQA iONIba Dosimetry GmbH202011
+6K191610RTappSegana, LLC20191—
+6K191761Mobius3DVarian Medical Systems, Inc.20195—
+6K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+6K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+6K182966PLANET Onco DoseDosisoft20191—
+6K182624MIM - MRT DosimetryMim Software, Inc.201853—
+6K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+6K182016Simplicit90YMirada Medical, Ltd.20183—
+6K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+6K181572Workflow BoxMirada Medical, Ltd.201825—
+6K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+6K173597Scenium VE20 SoftwareSiemens Medical Solutions USA, Inc.20180—
+6K173542Arterys Oncology DLArterys, Inc.20185—
+6K171350Collision CheckRadformation, Inc.20174—
+6K171754NovaPACSNovarad Corporation201741
+6K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V.201732
+6K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+6K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+6K161201ClearRead CTRiverain Technologies, LLC20165—