510(k) Report

Devices descending from K013630

123 later devices reach Isite Radiology through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp.20120—
+1K080290XviewnetAmerican Radiologist Network, Inc.20081—
+1K061421Erad PacsErad, Inc.200614—
+1K032157Telemis-Medical SolutionTelemis S.A.20030—
+1K031778Practicebuilder 1-2-3Erad Imagemedical Corp.20030—
+1K031311Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc.2003115—
+1K030751Ipacs PrismRealtimeimage, Inc.20033—
+2K141329RadspaTelerad Tech Private Limited20140—
+2K132799Clariso PacsClariso, Inc.20134—
+2K120995Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc.20127—
+2K081792Spy Analysis Toolkit, Model SA9000Novadaq Technologies, Inc.20080—
+2K082318Centricity Pacs IWGe Healthcare Dynamic Imaging Solutions2008187
+2K050298Ipacs Prism-5.0Realtimeimage, Inc.20050—
+2K042313Integradweb MPR/MipDynamic Imaging, Inc.2004114—
+3K241223eRAD PACSErad, Inc.20240—
+3K161341Lifesys PacsLifetrack Medical Systems, Inc.20170—
+3K152977DG PacsDicom Grid, Inc.201641
+3K151957BOX DICOM ViewerBox, Inc.20153—
+3K121387Centricity Pacs-IWGe Healthcare Integrated IT Solutions2012161
+3K102000ImagysKeosys Sas20103—
+3K091631Accessnet, Accessmed, Accessrad, MedviewAspyra, Inc.20100—
+3K070089Syntermed LiveSyntermed, Inc.20070—
+3K052545Infinitt G3 PacsInfinitt Co., Ltd.200520—
+3K052358Etiam Star Pacs ComponentsEtiam, S.A.200556—
+4K202335Ambra ProViewerDicom Grid Inc Dba Ambra Health202021
+4K200822BraidBraid.Health20201—
+4K201296i-Rapha SolutionIrm, Inc.20200—
+4K180549ZED LinkZed Technologies20180—
+4K172803Infinitt PACS 7.0Infinitt Healthcare Co., Ltd.20173—
+4K163290INFINITT ULiteInfinitt Co., Ltd.20176—
+4K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+4K131392Etiam Pacs ComponentsEtiam S.A.S.U.20130—
+4K123174Centricity Pacs-IW with Universal ViewerGE Healthcare20121510
+4K090481Demasq Imaging Spftware DeviceDemasq Limited20091—
+4K082990Infinitt XelisInfinitt Co., Ltd.20086—
+4K062488IQ-System Pacs SystemImage Information Systems, Ltd.200655—
+5K241694ZeTTA PACSTae Young Soft Co., Ltd.20250—
+5K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+5K240385VINTMediimg Corporation20240—
+5K240839OpenRad CloudOpenrad Services Uk, Ltd.20240—
+5K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+5K223660SaintViewInviz Corporation20230—
+5K231360Ambra PACSDicom Grid Dba Ambra Health202301
+5K211655aPROMISEExini Diagnostics AB20211—
+5K211480NubeXTechheim Co., Ltd.20215—
+5K181318Onis-PacsDigitalcore Co., Ltd.20181—
+5K173241Med-TabPlum Medical Solutions GmbH20180—
+5K153284Synaptive ImageDrive ProSynaptive Medical, Inc.201601
+5K152716EV Insite SystemPsp Corporation20160—
+5K150420Centricity Universal ViewerGE Healthcare2015315
+5K141561VM Pacs with VM Medical WorkstationVisual Medica20150—
+5K131977Centricity Universal Viewer Zero Footprint ClientGE Healthcare201368
+5K111660Xelis CardiacInfinitt Co., Ltd.20110—
+5K111613Xelis FusionInfinitt Co., Ltd.20110—
+5K103130Xelis 3DInfinitt Co., Ltd.20110—
+5K100837Pacentric Connect, Traveler and WebFimreite Software AS20100—
+5K102684Xelis DentalInfinitt Co., Ltd.20102—
+5K092328Med-Seg, Model BTMS 1000Bartron Medical Imaging, Inc.20100—
+5K063470Aycan Workstation OsirixAycan Digitalsysteme GmbH200749—
+6K261874Syneris PACS v.1.0.1.0Syneris20260—
+6K222781AugmentoDeeptek Medical Imaging Private Limited20234—
+6K220590aPROMISE XExini Diagnostics AB20220—
+6K193369Xelis Dental 2.0Infinitt Healthcare Co., Ltd.20200—
+6K182419Centricity Universal ViewerGE Healthcare201828
+6K151371Corporate Dental Imaging (CDI) ApplicationU.S. Army Dental Command (Dencom)20150—
+6K141881RapidresultsRamsoft, Inc.20145—
+6K103546Aycan Workstation Osirix ProAycan Digitalsysteme GmbH20110—
+6K101342Osirix MDPixmeo Sarl201044—
+6K082041Fiatlux VisualizeFiatlux Imaging, Inc.20081—
+6K073176Kanteron Dicom Station (KDS), Model 3.0Monica Veytia20080—
+7K251030Sirona Advanced Imaging SuiteSirona Medical20250—
+7K242838QuickRadAikenist Technologies Pvt, Ltd.20250—
+7K232891Carpl (Carpl)Carpl Ai, Inc.20242—
+7K232589Horos MD™Icat Solutions, Ltd.20241—
+7K222476OmegaAI Image ViewerRamsoft, Inc.20223—
+7K212565CoverScan v1Perspectum, Ltd.20221—
+7K211312Universal ViewerGE Healthcare202112
+7K201092LSNImaging Biometrics, LLC20200—
+7K181460OnePacs SystemOnepacs, LLC20180—
+7K181962CubeVueCurvebeam, LLC20180—
+7K163158MEDSYNAPSE Zero Footprint ViewerMedsynaptic Private, Ltd.20160—
+7K150976CollageAnatomage, Inc.20150—
+7K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+7K090295Bodyviz, Model 100Visual Medical Solutions, LLC20090—
+8K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)20260—
+8K254237Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl.20260—
+8K253639ViewGE Healthcare20260—
+8K253008maiLinkMaihub Corp.20260—
+8K242552Horos MobileIcat Solutions, Ltd.20250—
+8K241546aiCockpit AI ViewerFovia, Inc.20250—
+8K242362Lightning ViewerNexsys Electronics Inc. Dba Medweb20240—
+8K230294CoverScan (CoverScan v1.1)Perspectum20230—
+8K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+8K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+8K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+9K243509Archer PSI System3D-Side20250—
+9K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+9K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+10K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+10K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—