510(k) Report

Devices descending from K954678

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K980648Pro VisionAlgotec Systems, Ltd.1998672—
+1K971347MedisurfInternational Regulatory Consultants19976—
+2K031473Rational Imaging PacsIntuitive Imaging Informatics, LLC20030—
+2K992654Plug 'N View 3D, Version 1.0Voxar Limited1999670—
+2K984405Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000Intracom Corp.19990—
+2K982769Mitra Imaging Inc. ExhibitMitra Imaging, Inc.199811
+2K981053Kodak Digital Sciences (KDS) Image ViewEastman Kodak Company19981—
+2K980918JPACSPhilips Medical Systems (Cleveland), Inc.19980—
+3K0631073DNET SuiteBiotronics3D, Ltd.200634—
+3K062164Resolutionmd, Version 1.3Calgary Scientific, Inc.20062—
+3K052284Reformat GatewayInfinitt Co., Ltd.20050—
+3K0430973VISEON3Mensio Medical Imaging BV200452—
+3K041286Dynacad V1.0Mri Devices Corp.200417—
+3K041761RapidiacolonInfinitt Co., Ltd.20047—
+3K033955RTISTMirada Solutions, Ltd.200475—
+3K031779CadstreamConfirma, Inc.200319—
+3K022970Amicas Light Beam Workstation, Model 1.0Amicas, Inc.200211—
+3K022938Vizdexter Version 2.0; Dextroscope MK8; Dextrobeam MK3Volume Interactions Pte, Ltd.20020—
+3K022692Voxelplus PacsMevisys Co., Ltd.2002252—
+3K020546Fusion 7DMirada Solutions, Ltd.2002442—
+3K013878Cybermed, Inc., V-WorksCybermed, Inc.2001140—
+3K012779Iconnection 3DHinnovation, Inc.200131—
+3K012290Rapidia3D Med Co., Ltd.200178—
+3K012097VortexUltravisual Medical Systems200118—
+3K992698Stentor, PageviewStentor, Inc.19990—
+4K240839OpenRad CloudOpenrad Services Uk, Ltd.20240—
+4K191959QuantX Breast MRI Biopsy Guidance PluginQlarity Imaging20190—
+4K173744ProFuse CADEigen20181—
+4K133030Dynacad/Prostate Interventional (Dynaloc/Prostate)Invivo Corporation201411
+4K101228Mirada XDMirada Medical, Ltd.201070—
+4K100236Stair Systems Pacs & Dicom ViewerStair Systems, Inc.20101—
+4K090038Syngo BrevisSiemens Medical Solutions USA, Inc.20090—
+4K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc.200901
+4K081556Cadstream, Version 5.0Confirma, Inc.20099—
+4K083673Carestream Pacs, Model Carestream Pacs ViiCarestream Health, Inc.200812—
+4K082990Infinitt XelisInfinitt Co., Ltd.20086—
+4K081792Spy Analysis Toolkit, Model SA9000Novadaq Technologies, Inc.20080—
+4K081215VoluminaKjaya Medical, LLC20080—
+4K0810933-D Imaging WorkstationEigen, LLC200831—
+4K0726533VISEON/Surgery3Mensio Medical Imaging BV200851—
+4K071950Syngo TruedSiemens Medical Solutions USA, Inc.2007201—
+4K070464ONDEMAND3DCybermed, Inc.200714—
+4K062477Amicas Vision Series Pacs, Model 4.3Amicas, Inc.20067—
+4K061421Erad PacsErad, Inc.200614—
+4K061418QuantivaTomographix IP, Ltd.20060—
+4K061214Aquariusaps ServerTerarecon,Inc.2006134—
+4K061126AccurexCybermed, Inc.20063—
+4K060378VITREA2 Version 3.8.1Vital Images, Inc.20061—
+4K053455Encompass.NetEmpiric Systems, LLC20060—
+4K052467Brain Viewrx Viewer, Version 1.0Kyron Clinical Imaging, Inc.20055—
+4K053281Evms (Enterprise Visual Medical System Software)Emageon, Inc.200509
+4K053155VimplantCybermed, Inc.200563—
+4K052305Mri Soft Tissue Motion Correction Software VA10ASiemens Medical Solutions USA, Inc.200534—
+4K051528Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG2005226—
+4K051037Imageqube PacsIntuitive Imaging Informatics, LLC20052—
+4K050033LucionMevisys Co., Ltd.20053—
+4K042008UltravisualEmageon Uv, Inc.20041—
+4K041020Cadstream Version 3.1Confirma, Inc.20040—
+4K040876Iconnection, Version 3.2.0.0 Medical Image Processing SoftwareVital Images, Inc.200430—
+4K040305VITREA2 Version 3.5Vital Images, Inc.2004164—
+4K031778Practicebuilder 1-2-3Erad Imagemedical Corp.20030—
+4K031886Sonoview Pro by Medison CO., LTD.Medison Co., Ltd.20035—
+4K030457Rex, Version 3.0Pointdx, Inc.200376—
+4K021099Rex, Version 1.0Pointdx, Inc.200277—
+5K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+5K222222Artemis, Artemis TPO, Artemis MXEigen20230—
+5K222683Fibroid Mapping Reviewer Application (FMRA)Nesa Medtech Private Limited20230—
+5K220779XDMirada Medical, Ltd.20220—
+5K210719Change Healthcare Anatomical AIChange Healthcare Canada Company20210—
+5K191278Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix)20190—
+5K173312ProBx SoftwareHarmonus, Inc.20180—
+5K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+5K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+5K170195QuantXQuantitative Insights, Inc.20174—
+5K162474ArtemisEigen20163—
+5K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+5K153166Fusion BxFocal Healtcare, Inc.20161—
+5K153073UroNav (Version 2.0)Invivo Corporation201511—
+5K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+5K151115MR Core SoftwareVital Images, Inc.20153—
+5K132853NovapacsNovarad Corp.201462
+5K142048Emprint Procedure Planning ApplicationCovidien, LLC20143—
+5K141329RadspaTelerad Tech Private Limited20140—
+5K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+5K132799Clariso PacsClariso, Inc.20134—
+5K131498Iqqa-Liver Multimodality SoftwareEdda Technology, Inc.201316—
+5K121916IntuitionTerarecon,Inc.201351
+5K124048ImagequbeIntuitive Imaging Informatics, LLC20130—
+5K120995Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc.20127—
+5K121213VitreaadvancedVital Images, Inc.201281
+5K122329BiojetJet Soft Srl20120—
+5K120734Microsoft Amalga Uis Image Processing ModuleMicrosoft Corp.20120—
+5K1203673MENSIO WorkstationPie Medical Imaging BV201249—
+5K120161Alphapoint Imaging SoftwareRadlogics, Inc.20120—
+5K112008Touchpacs SuiteTouch Medical Solutions, Inc.20120—
+5K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+5K113543ONDEMAND3DCybermed, Inc.20119—
+5K100784UC-Care Navigo SytemUC-CARE, Ltd.20113—
+5K110919Carestream PacsCarestream Health, Inc.2011850
+5K111660Xelis CardiacInfinitt Co., Ltd.20110—