510(k) Report

Devices descending from K896095

850 later devices reach Images-on-Call Teleradiology System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K170171IOLMaster 700Carl Zeiss Meditec, AG201731
+9K163221Mazor XMazor Robotics, Ltd.201719—
+9K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+9K161130ResolutionMDCalgary Scientific, Inc.20164—
+9K161479hipEOSOnefit Medical20169—
+9K160407spineEOSOnefit Medical20166—
+9K153103CARESTREAM Vue PACSCarestream Health, Inc.201601
+9K143368GenIQGe Medical Systems, LLC20150—
+9K142648SPINEDESIGN Spine Surgery Planning (Software Application)Medtronic Sofamor Danek USA, Inc.20150—
+9K15100721.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)Jvckenwood Corporation20150—
+9K150843syngo®.via (version VB10A)Siemens AG201546—
+9K143718Mammography Color Display DP-M3010Canon, Inc.20150—
+9K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+9K142142Quality ReportsSun Nuclear Corporation20145—
+9K141572Mosaiq Oncology Information SystemImpac Medical Systems, Inc.20141311
+9K1407028MP Color LCD Monitor, Radiforce RX850Eizo Corporation201401
+9K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+9K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+9K13368621.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035)Jvckenwood Corporation20141—
+9K132095Olea SphereOlea Medical201320—
+9K121447Ischema View RapidIschemaview, Inc.201329—
+9K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+9K11344321.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023)Totoku Electric Co., Ltd.20112—
+9K092954Cadstream Version 5Confirma, Inc.200983
+10K261500KBA3D (v2.4.0)S.M.A.I.O20260—
+10K260500ResolutionMDResolutionMD, Inc.20260—
+10K260694Zeiss Clinic 360Carl Zeiss Meditec, AG20260—
+10K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—
+10K260077OrthoGrid Hip AI® 4.0OrthoGrid Systems, Inc.20260—
+10K253078ART.1-USSeetreat Pty, Ltd.20260—
+10K260321HipGuide (V 1.0.0.0)Orthopedic Driven Imaging, LLC20260—
+10K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+10K253962ClearCheck (RADCC V2.7)Radformation, Inc.20260—
+10K260479TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202611
+10K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+10K251577Laia XRAugmented Reality Software S.L.20260—
+10K252922Neosoma Brain MetsNeosoma, Inc.20250—
+10K252665brAIn™ Shoulder PositioningAvatar Medical20250—
+10K252476Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…Brainlab AG20250—
+10K252214AIAS CephalonMetamorphosis GmbH20250—
+10K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+10K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+10K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+10K243810TraumaCad Neo (1.1)Brainlab, Ltd.20250—
+10K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+10K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+10K243069Lumys (V1)Intradys20250—
+10K243697MySpine WebPlannerMedacta International S.A.20250—
+10K250416GBrain MRIGalileo Cds, Inc.20251—
+10K243292brAIn™ Shoulder PositioningAvatar Medical20250—
+10K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+10K250035Contour ProtégéAI+Mim Software, Inc.20251—
+10K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+10K240926PeekMed webPeek Health, S.A.20246—
+10K242709JLK-PwiJLK, Inc.20240—
+10K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+10K242556JLK-CTPJLK, Inc.20240—
+10K241837Limbus ContourLimbus Ai, Inc.20240—
+10K240094LumiNE US; LumiAugmedit B.V.20240—
+10K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+10K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+10K240172Preview ShoulderGenesis Software Innovations20240—
+10K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+10K233421Rescan 700Carl Zeiss Meditec, AG20240—
+10K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+10K230985Planmeca VisoPlanmeca Oy20233—
+10K231130TumorSight VizSimBioSys, Inc.20232—
+10K232944CALLISTO eyeCarl Zeiss Meditec, AG20230—
+10K232086spineEOSEos Imaging20235—
+10K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+10K231656Brainomix 360 e-MRIBrainomix Limited20230—
+10K231577MOBILETT ImpactSiemens Medical Solutions20230—
+10K231185MapRTVision Rt, Ltd.20231—
+10K223555Brainomix 360 e-CTPBrainomix Limited20230—
+10K230082Auto SegmentationGe Medical Systems, LLC20231—
+10K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+10K221706AccuContourManteia Technologies Co., Ltd.20232—
+10K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+10K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+10K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+10K213891RealNowYiwei Medical Technology Co., Ltd.20230—
+10K220630TorchTM SoftwareVoximetry, Incorporated20221—
+10K220663AccuCTPArteryFlow Technology Co., Ltd.20221—
+10K222428Syngo Dynamics (Version VA40F)Siemens Medical Solutions USA, Inc.20222—
+10K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+10K220767TeleScanBb Imaging20221—
+10K213779Customize3D-Side S.A.20221—
+10K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+10K210670BU-CADTaihao Medical, Inc.20213—
+10K213628VBrainVysioneer, Inc.20210—
+10K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+10K212116VBrain-OARVysioneer, Inc.20211—
+10K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+10K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+10K203669Mobius3DVarian Medical Systems, Inc.20213—
+10K202350SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+10K202353SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20202—
+10K202487HealthJOINTZebra Medical Vision, Ltd.20200—
+10K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+10K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—