510(k) Report

Devices descending from K980648

672 later devices reach Pro Vision through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992654Plug 'N View 3D, Version 1.0Voxar Limited1999670—
+1K984405Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000Intracom Corp.19990—
+2K0631073DNET SuiteBiotronics3D, Ltd.200634—
+2K062164Resolutionmd, Version 1.3Calgary Scientific, Inc.20062—
+2K052284Reformat GatewayInfinitt Co., Ltd.20050—
+2K0430973VISEON3Mensio Medical Imaging BV200452—
+2K041286Dynacad V1.0Mri Devices Corp.200417—
+2K041761RapidiacolonInfinitt Co., Ltd.20047—
+2K033955RTISTMirada Solutions, Ltd.200475—
+2K031779CadstreamConfirma, Inc.200319—
+2K022970Amicas Light Beam Workstation, Model 1.0Amicas, Inc.200211—
+2K022938Vizdexter Version 2.0; Dextroscope MK8; Dextrobeam MK3Volume Interactions Pte, Ltd.20020—
+2K022692Voxelplus PacsMevisys Co., Ltd.2002252—
+2K020546Fusion 7DMirada Solutions, Ltd.2002442—
+2K013878Cybermed, Inc., V-WorksCybermed, Inc.2001140—
+2K012779Iconnection 3DHinnovation, Inc.200131—
+2K012290Rapidia3D Med Co., Ltd.200178—
+2K012097VortexUltravisual Medical Systems200118—
+3K240839OpenRad CloudOpenrad Services Uk, Ltd.20240—
+3K191959QuantX Breast MRI Biopsy Guidance PluginQlarity Imaging20190—
+3K173744ProFuse CADEigen20181—
+3K133030Dynacad/Prostate Interventional (Dynaloc/Prostate)Invivo Corporation201411
+3K101228Mirada XDMirada Medical, Ltd.201070—
+3K100236Stair Systems Pacs & Dicom ViewerStair Systems, Inc.20101—
+3K090038Syngo BrevisSiemens Medical Solutions USA, Inc.20090—
+3K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc.200901
+3K081556Cadstream, Version 5.0Confirma, Inc.20099—
+3K083673Carestream Pacs, Model Carestream Pacs ViiCarestream Health, Inc.200812—
+3K082990Infinitt XelisInfinitt Co., Ltd.20086—
+3K081792Spy Analysis Toolkit, Model SA9000Novadaq Technologies, Inc.20080—
+3K081215VoluminaKjaya Medical, LLC20080—
+3K0810933-D Imaging WorkstationEigen, LLC200831—
+3K0726533VISEON/Surgery3Mensio Medical Imaging BV200851—
+3K071950Syngo TruedSiemens Medical Solutions USA, Inc.2007201—
+3K070464ONDEMAND3DCybermed, Inc.200714—
+3K062477Amicas Vision Series Pacs, Model 4.3Amicas, Inc.20067—
+3K061421Erad PacsErad, Inc.200614—
+3K061418QuantivaTomographix IP, Ltd.20060—
+3K061214Aquariusaps ServerTerarecon,Inc.2006134—
+3K061126AccurexCybermed, Inc.20063—
+3K060378VITREA2 Version 3.8.1Vital Images, Inc.20061—
+3K053455Encompass.NetEmpiric Systems, LLC20060—
+3K052467Brain Viewrx Viewer, Version 1.0Kyron Clinical Imaging, Inc.20055—
+3K053281Evms (Enterprise Visual Medical System Software)Emageon, Inc.200509
+3K053155VimplantCybermed, Inc.200563—
+3K052305Mri Soft Tissue Motion Correction Software VA10ASiemens Medical Solutions USA, Inc.200534—
+3K051528Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG2005226—
+3K051037Imageqube PacsIntuitive Imaging Informatics, LLC20052—
+3K050033LucionMevisys Co., Ltd.20053—
+3K042008UltravisualEmageon Uv, Inc.20041—
+3K041020Cadstream Version 3.1Confirma, Inc.20040—
+3K040876Iconnection, Version 3.2.0.0 Medical Image Processing SoftwareVital Images, Inc.200430—
+3K040305VITREA2 Version 3.5Vital Images, Inc.2004164—
+3K031778Practicebuilder 1-2-3Erad Imagemedical Corp.20030—
+3K031886Sonoview Pro by Medison CO., LTD.Medison Co., Ltd.20035—
+3K030457Rex, Version 3.0Pointdx, Inc.200376—
+3K021099Rex, Version 1.0Pointdx, Inc.200277—
+4K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+4K222222Artemis, Artemis TPO, Artemis MXEigen20230—
+4K222683Fibroid Mapping Reviewer Application (FMRA)Nesa Medtech Private Limited20230—
+4K220779XDMirada Medical, Ltd.20220—
+4K210719Change Healthcare Anatomical AIChange Healthcare Canada Company20210—
+4K191278Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix)20190—
+4K173312ProBx SoftwareHarmonus, Inc.20180—
+4K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+4K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+4K170195QuantXQuantitative Insights, Inc.20174—
+4K162474ArtemisEigen20163—
+4K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+4K153166Fusion BxFocal Healtcare, Inc.20161—
+4K153073UroNav (Version 2.0)Invivo Corporation201511—
+4K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+4K151115MR Core SoftwareVital Images, Inc.20153—
+4K132853NovapacsNovarad Corp.201462
+4K142048Emprint Procedure Planning ApplicationCovidien, LLC20143—
+4K141329RadspaTelerad Tech Private Limited20140—
+4K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+4K132799Clariso PacsClariso, Inc.20134—
+4K131498Iqqa-Liver Multimodality SoftwareEdda Technology, Inc.201316—
+4K121916IntuitionTerarecon,Inc.201351
+4K124048ImagequbeIntuitive Imaging Informatics, LLC20130—
+4K120995Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc.20127—
+4K121213VitreaadvancedVital Images, Inc.201281
+4K122329BiojetJet Soft Srl20120—
+4K120734Microsoft Amalga Uis Image Processing ModuleMicrosoft Corp.20120—
+4K1203673MENSIO WorkstationPie Medical Imaging BV201249—
+4K120161Alphapoint Imaging SoftwareRadlogics, Inc.20120—
+4K112008Touchpacs SuiteTouch Medical Solutions, Inc.20120—
+4K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+4K113543ONDEMAND3DCybermed, Inc.20119—
+4K100784UC-Care Navigo SytemUC-CARE, Ltd.20113—
+4K110919Carestream PacsCarestream Health, Inc.2011850
+4K111660Xelis CardiacInfinitt Co., Ltd.20110—
+4K111613Xelis FusionInfinitt Co., Ltd.20110—
+4K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+4K103130Xelis 3DInfinitt Co., Ltd.20110—
+4K110256The IC-Pro SystemPaieon, Inc.201115—
+4K103182Triana, Picture Archiving and Communications SystemGenoray Co., Ltd.20110—
+4K102687Mirada RTMirada Medical, Ltd.201037—
+4K102684Xelis DentalInfinitt Co., Ltd.20102—