510(k) Report

Devices descending from K042313

114 later devices reach Integradweb MPR/Mip through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102000ImagysKeosys Sas20103—
+1K082318Centricity Pacs IWGe Healthcare Dynamic Imaging Solutions2008187
+1K070089Syntermed LiveSyntermed, Inc.20070—
+1K061421Erad PacsErad, Inc.200614—
+1K052545Infinitt G3 PacsInfinitt Co., Ltd.200520—
+1K052358Etiam Star Pacs ComponentsEtiam, S.A.200556—
+2K172803Infinitt PACS 7.0Infinitt Healthcare Co., Ltd.20173—
+2K163290INFINITT ULiteInfinitt Co., Ltd.20176—
+2K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+2K141329RadspaTelerad Tech Private Limited20140—
+2K132799Clariso PacsClariso, Inc.20134—
+2K131392Etiam Pacs ComponentsEtiam S.A.S.U.20130—
+2K120995Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc.20127—
+2K121387Centricity Pacs-IWGe Healthcare Integrated IT Solutions2012161
+2K091631Accessnet, Accessmed, Accessrad, MedviewAspyra, Inc.20100—
+2K090481Demasq Imaging Spftware DeviceDemasq Limited20091—
+2K082990Infinitt XelisInfinitt Co., Ltd.20086—
+2K062488IQ-System Pacs SystemImage Information Systems, Ltd.200655—
+3K241694ZeTTA PACSTae Young Soft Co., Ltd.20250—
+3K241223eRAD PACSErad, Inc.20240—
+3K240385VINTMediimg Corporation20240—
+3K223660SaintViewInviz Corporation20230—
+3K211655aPROMISEExini Diagnostics AB20211—
+3K211480NubeXTechheim Co., Ltd.20215—
+3K181318Onis-PacsDigitalcore Co., Ltd.20181—
+3K173241Med-TabPlum Medical Solutions GmbH20180—
+3K161341Lifesys PacsLifetrack Medical Systems, Inc.20170—
+3K152977DG PacsDicom Grid, Inc.201641
+3K151957BOX DICOM ViewerBox, Inc.20153—
+3K123174Centricity Pacs-IW with Universal ViewerGE Healthcare20121510
+3K111660Xelis CardiacInfinitt Co., Ltd.20110—
+3K111613Xelis FusionInfinitt Co., Ltd.20110—
+3K103130Xelis 3DInfinitt Co., Ltd.20110—
+3K100837Pacentric Connect, Traveler and WebFimreite Software AS20100—
+3K102684Xelis DentalInfinitt Co., Ltd.20102—
+3K092328Med-Seg, Model BTMS 1000Bartron Medical Imaging, Inc.20100—
+3K063470Aycan Workstation OsirixAycan Digitalsysteme GmbH200749—
+4K261874Syneris PACS v.1.0.1.0Syneris20260—
+4K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+4K222781AugmentoDeeptek Medical Imaging Private Limited20234—
+4K220590aPROMISE XExini Diagnostics AB20220—
+4K202335Ambra ProViewerDicom Grid Inc Dba Ambra Health202021
+4K200822BraidBraid.Health20201—
+4K201296i-Rapha SolutionIrm, Inc.20200—
+4K193369Xelis Dental 2.0Infinitt Healthcare Co., Ltd.20200—
+4K180549ZED LinkZed Technologies20180—
+4K153284Synaptive ImageDrive ProSynaptive Medical, Inc.201601
+4K152716EV Insite SystemPsp Corporation20160—
+4K151371Corporate Dental Imaging (CDI) ApplicationU.S. Army Dental Command (Dencom)20150—
+4K150420Centricity Universal ViewerGE Healthcare2015315
+4K141561VM Pacs with VM Medical WorkstationVisual Medica20150—
+4K131977Centricity Universal Viewer Zero Footprint ClientGE Healthcare201368
+4K103546Aycan Workstation Osirix ProAycan Digitalsysteme GmbH20110—
+4K101342Osirix MDPixmeo Sarl201044—
+4K082041Fiatlux VisualizeFiatlux Imaging, Inc.20081—
+4K073176Kanteron Dicom Station (KDS), Model 3.0Monica Veytia20080—
+5K251030Sirona Advanced Imaging SuiteSirona Medical20250—
+5K242838QuickRadAikenist Technologies Pvt, Ltd.20250—
+5K240839OpenRad CloudOpenrad Services Uk, Ltd.20240—
+5K232891Carpl (Carpl)Carpl Ai, Inc.20242—
+5K232589Horos MD™Icat Solutions, Ltd.20241—
+5K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+5K231360Ambra PACSDicom Grid Dba Ambra Health202301
+5K212565CoverScan v1Perspectum, Ltd.20221—
+5K201092LSNImaging Biometrics, LLC20200—
+5K182419Centricity Universal ViewerGE Healthcare201828
+5K181460OnePacs SystemOnepacs, LLC20180—
+5K181962CubeVueCurvebeam, LLC20180—
+5K150976CollageAnatomage, Inc.20150—
+5K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+5K141881RapidresultsRamsoft, Inc.20145—
+5K090295Bodyviz, Model 100Visual Medical Solutions, LLC20090—
+6K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)20260—
+6K253008maiLinkMaihub Corp.20260—
+6K242552Horos MobileIcat Solutions, Ltd.20250—
+6K230294CoverScan (CoverScan v1.1)Perspectum20230—
+6K222476OmegaAI Image ViewerRamsoft, Inc.20223—
+6K211312Universal ViewerGE Healthcare202112
+6K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+6K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+6K163158MEDSYNAPSE Zero Footprint ViewerMedsynaptic Private, Ltd.20160—
+6K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+7K254237Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl.20260—
+7K253639ViewGE Healthcare20260—
+7K243509Archer PSI System3D-Side20250—
+7K241546aiCockpit AI ViewerFovia, Inc.20250—
+7K242362Lightning ViewerNexsys Electronics Inc. Dba Medweb20240—
+7K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+7K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+8K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+8K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+8K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+9K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+9K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+9K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+9K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+9K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+9K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+9K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+9K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—