510(k) Report

Devices descending from K955092

219 later devices reach Accurad Image Management System, Autorad, Regustration Station, Archive… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K090481Demasq Imaging Spftware DeviceDemasq Limited20091—
+5K082990Infinitt XelisInfinitt Co., Ltd.20086—
+5K062488IQ-System Pacs SystemImage Information Systems, Ltd.200655—
+6K253834Visuref 600Carl Zeiss Vision GmbH20260—
+6K241694ZeTTA PACSTae Young Soft Co., Ltd.20250—
+6K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+6K240385VINTMediimg Corporation20240—
+6K234076iCare ALTIUS CWCentervue S.P.A.20240—
+6K240839OpenRad CloudOpenrad Services Uk, Ltd.20240—
+6K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+6K223660SaintViewInviz Corporation20230—
+6K231360Ambra PACSDicom Grid Dba Ambra Health202301
+6K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…Nidek Co., Ltd.20230—
+6K211715RetinAI DiscoveryRetinai Medical AG20221—
+6K211655aPROMISEExini Diagnostics AB20211—
+6K211480NubeXTechheim Co., Ltd.20215—
+6K200422Image Quality Analyzer (IQA)Visionquest Biomedical, Inc.20200—
+6K200954Glaucoma ModuleTopcon Healthcare Solutions, Inc.20200—
+6K181501AfinaNeurovision Imaging, LLC20180—
+6K182376HarmonyTopcon Medical Systems, Inc.20184—
+6K181318Onis-PacsDigitalcore Co., Ltd.20181—
+6K180858CALLISTO eyeCarl Zeiss Meditec, AG20182—
+6K173241Med-TabPlum Medical Solutions GmbH20180—
+6K162743ViewPoint 6GE Medical Systems Ultrasound and Primary Care Diagnostics201601
+6K153284Synaptive ImageDrive ProSynaptive Medical, Inc.201601
+6K152716EV Insite SystemPsp Corporation20160—
+6K143275IOLMaster700Carl Zeiss Meditec, Inc.20154—
+6K150420Centricity Universal ViewerGE Healthcare2015315
+6K141561VM Pacs with VM Medical WorkstationVisual Medica20150—
+6K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG20145—
+6K131977Centricity Universal Viewer Zero Footprint ClientGE Healthcare201368
+6K122205EXINIExini Diagnostics AB20125—
+6K111660Xelis CardiacInfinitt Co., Ltd.20110—
+6K111613Xelis FusionInfinitt Co., Ltd.20110—
+6K103130Xelis 3DInfinitt Co., Ltd.20110—
+6K100837Pacentric Connect, Traveler and WebFimreite Software AS20100—
+6K102684Xelis DentalInfinitt Co., Ltd.20102—
+6K092328Med-Seg, Model BTMS 1000Bartron Medical Imaging, Inc.20100—
+6K063470Aycan Workstation OsirixAycan Digitalsysteme GmbH200749—
+7K261874Syneris PACS v.1.0.1.0Syneris20260—
+7K232555HarmonyTopcon Healthcare Solutions20231—
+7K231676CALLISTO eyeCarl Zeiss Meditec, AG20231—
+7K232088Altris IMSAltris, Inc.20230—
+7K222781AugmentoDeeptek Medical Imaging Private Limited20234—
+7K220590aPROMISE XExini Diagnostics AB20220—
+7K210396Harmony Referral SystemTopcon Healthcare Solutions EMEA Oy20211—
+7K193369Xelis Dental 2.0Infinitt Healthcare Co., Ltd.20200—
+7K191262aBSIExini Diagnostics AB20192—
+7K191051ARGOSSantec Corporation20190—
+7K180229RESCAN 700, CALLISTO eyeCarl Zeiss Meditec, AG20191—
+7K182419Centricity Universal ViewerGE Healthcare201828
+7K173444Quantitative Total Extensible Imaging (QTxI)Aiq Solutions, Inc.20181—
+7K170171IOLMaster 700Carl Zeiss Meditec, AG201731
+7K151371Corporate Dental Imaging (CDI) ApplicationU.S. Army Dental Command (Dencom)20150—
+7K141881RapidresultsRamsoft, Inc.20145—
+7K103546Aycan Workstation Osirix ProAycan Digitalsysteme GmbH20110—
+7K101342Osirix MDPixmeo Sarl201044—
+7K082041Fiatlux VisualizeFiatlux Imaging, Inc.20081—
+7K073176Kanteron Dicom Station (KDS), Model 3.0Monica Veytia20080—
+8K260694Zeiss Clinic 360Carl Zeiss Meditec, AG20260—
+8K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—
+8K251030Sirona Advanced Imaging SuiteSirona Medical20250—
+8K242838QuickRadAikenist Technologies Pvt, Ltd.20250—
+8K233998TRAQinform IQAiq Global, Inc.20240—
+8K232891Carpl (Carpl)Carpl Ai, Inc.20242—
+8K233421Rescan 700Carl Zeiss Meditec, AG20240—
+8K232589Horos MD™Icat Solutions, Ltd.20241—
+8K232944CALLISTO eyeCarl Zeiss Meditec, AG20230—
+8K222476OmegaAI Image ViewerRamsoft, Inc.20223—
+8K212565CoverScan v1Perspectum, Ltd.20221—
+8K211312Universal ViewerGE Healthcare202112
+8K201092LSNImaging Biometrics, LLC20200—
+8K181460OnePacs SystemOnepacs, LLC20180—
+8K173771IOLMaster 700Carl Zeiss Meditec, AG201811
+8K181962CubeVueCurvebeam, LLC20180—
+8K163158MEDSYNAPSE Zero Footprint ViewerMedsynaptic Private, Ltd.20160—
+8K150976CollageAnatomage, Inc.20150—
+8K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+8K090295Bodyviz, Model 100Visual Medical Solutions, LLC20090—
+9K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)20260—
+9K254237Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl.20260—
+9K253639ViewGE Healthcare20260—
+9K253008maiLinkMaihub Corp.20260—
+9K252633Unity DX (Udx)Cylite Pty., Ltd.20250—
+9K242552Horos MobileIcat Solutions, Ltd.20250—
+9K241546aiCockpit AI ViewerFovia, Inc.20250—
+9K242362Lightning ViewerNexsys Electronics Inc. Dba Medweb20240—
+9K230294CoverScan (CoverScan v1.1)Perspectum20230—
+9K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+9K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+9K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+10K243509Archer PSI System3D-Side20250—
+10K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+10K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+11K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+11K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+11K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+12K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+12K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+12K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—