510(k) Report

Devices descending from K904519

438 later devices reach Agfa Diagnostic Center (Adc) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K181892Ziostation2Ziosoft, Inc.20181—
+11K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+11K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+11K173475Merge PACSMerge Healthcare Incorporated201712
+11K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+11K163668SuitestensaEbit Srl20170—
+11K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+11K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+11K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+11K151233MonacoImpac Medical Systems, Inc.201569
+11K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+12K261641Lower Limb AI (LLAI)AI Planning Logic, Inc.20260—
+12K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+12K243685MammoScreen BDTherapixel20250—
+12K252362GBrain MRIGalileo Cds, Inc.20250—
+12K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+12K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+12K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+12K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+12K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+12K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+12K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+12K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+12K232479ART-PlanTherapanacea20232—
+12K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+12K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+12K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+12K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+12K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+12K203744Arterys MICAArterys, Inc.20221—
+12K213976Contour ProtégéAIMim Software, Inc.20224—
+12K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+12K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+12K201948AcroDTI VisualizerAcroviz, Inc.20200—
+12K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+12K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+12K200315Ziostation2Ziosoft, Inc.20200—
+12K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+12K192455Merge PACSMerge Healthcare Incorporated201904
+12K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+12K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+12K183037Monaco RTP SystemElekta, Inc.201856
+12K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+12K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+12K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+12K142647mint LesionMint Medical GmbH201523
+13K260528OncoStudioOncosoft. Inc.,20260—
+13K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+13K253078ART.1-USSeetreat Pty, Ltd.20260—
+13K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+13K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+13K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+13K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+13K252539Tempus PixelArterys, Inc.20250—
+13K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+13K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+13K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+13K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+13K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+13K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+13K223774Contour ProtégéAIMim Software, Inc.20233—
+13K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+13K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+13K220929ExcelsiorMerit Cro, Inc.20220—
+13K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+13K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+13K202229AI MetricsAi Metrics, LLC20200—
+13K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+13K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+13K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+13K200899Quantib AI NodeQuantib B.V.20200—
+13K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+13K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+13K190178Monaco RTP SystemElekta, Inc.201945
+13K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+13K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+14K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+14K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+14K252571mdprostateMediaire GmbH20260—
+14K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+14K253690LungMapsSiemens Healthineers AG20260—
+14K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+14K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+14K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+14K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+14K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+14K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+14K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+14K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+14K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+14K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+14K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+14K231765Contour ProtégéAIMim Software, Inc.20232—
+14K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+14K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+14K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+14K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+14K202789Monaco Rtp SystemElekta Solutions AB20213—
+14K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+14K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—