510(k) Report

Devices descending from K980648

672 later devices reach Pro Vision through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+7K192455Merge PACSMerge Healthcare Incorporated201904
+7K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+7K183458exoplan 2.3Exocad GmbH20191—
+7K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+7K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+7K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+7K1730413DIEMME RealGUIDE3Diemme, Ltd.20182—
+7K182034Arterys MICAArterys, Inc.20183—
+7K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+7K182230Multi Modality ViewerVital Images, Inc.20180—
+7K180629DentiqGuide3D Industrial Imaging Co., Ltd.20181—
+7K180019CAAS WorkstationPie Medical Imaging BV20188—
+7K171534SurgicalPreviewEndo Vantage, LLC201710—
+7K163232Vitrea ViewVital Images, Inc.20177—
+7K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V.201732
+7K170521Trinity/3D Prostate SuiteKoelis20170—
+7K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+7K162799CliniviewPalodex Group OY201713—
+7K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+7K163122NobelClinician, DTX Studio implantNobel Biocare AB20172—
+7K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+7K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+7K161246Ez3D-i / E3Ewoosoft Co., Ltd.20162—
+7K151887syngo VSimSiemens Medical Solutions USA, Inc.20158—
+7K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+7K150757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.201513—
+7K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+7K133648Syngo, CT Dual EnergySiemens Medical Solutions USA, Inc.201416—
+7K132902Syngo Dual Energy Software PackageSiemens Medical Solutions USA, Inc.20140—
+7K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+7K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+7K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+7K121075Nervevision Software Systems3D Imaging Partners, Inc.20120—
+7K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc.201147
+7K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+7K072242Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd.20075—
+7K071331Vitrea Version 4.0Vital Images, Inc.2007821
+7K071000MyrianIntrasense20078—
+7K063548Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd.20076—
+8K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+8K251355X1-FFRSpectrawave, Inc.20250—
+8K250039HPACSHealthhub20250—
+8K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+8K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PADBrainlab AG20250—
+8K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+8K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+8K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+8K243069Lumys (V1)Intradys20250—
+8K250416GBrain MRIGalileo Cds, Inc.20251—
+8K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+8K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+8K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+8K240786AutoChamberHeartLung Corporation20241—
+8K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+8K241440HealthCCSngNano-X AI, Ltd.20240—
+8K233457RUSHutom, Inc.20240—
+8K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+8K232147CAAS WorkstationPie Medical Imaging BV20241—
+8K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+8K231683inHEART ModelsInheart, Sas20240—
+8K233080HealthFLDNano-X AI, Ltd.20240—
+8K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+8K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+8K231898DTX Studio Clinic (4.0)Nobel Biocare AB20231—
+8K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+8K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+8K230112CAC SoftwareImbio, Inc.20230—
+8K230223iCAC DeviceBunkerhill, Inc.20236—
+8K230023ART-PlanTherapanacea Sas20233—
+8K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+8K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+8K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+8K213302exoplanExocad GmbH202201
+8K211713AngioCloud ServiceAngiocloud, LLC20220—
+8K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+8K210632Contour ProtegeAIMim Software, Inc.20215—
+8K203765ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter…Zirkonzahn Srl20210—
+8K203156DTX Studio ClinicNobel Biocare AB202010—
+8K201710A View LCSCoreline Soft Co., Ltd.20200—
+8K201948AcroDTI VisualizerAcroviz, Inc.20200—
+8K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+8K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+8K192437Arterys MICAArterys, Inc.20202—
+8K190049Sim&SizeSim&Cure20198—
+8K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+8K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+8K190764SurgicalARMedivis, Inc.20196—
+8K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+8K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+8K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+8K172224DTX Studio diagnoseNobel Biocare AB20180—
+8K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+8K163071vascuCAPElucid Bioimaging, Inc.20173—
+8K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+8K163539Ez3D-i / E3Ewoosoft Co., Ltd.20161—
+8K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+8K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+8K151233MonacoImpac Medical Systems, Inc.201569
+8K150258Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc.201515—