510(k) Report

Devices descending from K980648

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+8K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc.20142—
+8K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+8K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+8K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc.201235
+8K121023Spectrum V.0Intrinsic Medical Imaging20120—
+8K120207VISIAMeVis Medical Solutions AG20120—
+8K110071Cor AnalyzerRcadia Medical Imaging, Ltd.20114—
+8K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+8K083691BonevueMicromri, Inc.20090—
+8K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+8K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+8K072821Vitrea 4DCTVital Images, Inc.2008171
+9K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+9K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+9K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—
+9K260166Bunkerhill Contrast CACBunkerHill Health20260—
+9K252029AI-CVDHeartLung Corporation20250—
+9K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+9K252086DTX Studio AssistNobel Biocare C/O Medicim NV20250—
+9K250662Bunkerhill MACBunkerHill Health20250—
+9K252362GBrain MRIGalileo Cds, Inc.20250—
+9K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+9K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+9K243769QFR (3.0)Qfr Solutions BV20250—
+9K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+9K243229Bunkerhill AVCBunkerHill Health20253—
+9K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+9K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+9K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+9K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+9K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+9K230006AnkyrasMentice Spain S.L.20231—
+9K232479ART-PlanTherapanacea20232—
+9K230249IkshanaImmersivetouch20231—
+9K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+9K221870CarnaLife HoloMedapp S.A.20230—
+9K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+9K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+9K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+9K213215VSI HoloMedicineApoqlar GmbH20222—
+9K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+9K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+9K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+9K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+9K213562DTX Studio Clinic 3.0Nobel Biocare AB20229—
+9K203744Arterys MICAArterys, Inc.20221—
+9K213976Contour ProtégéAIMim Software, Inc.20224—
+9K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+9K202322Sim&SizeSim&Cure20205—
+9K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+9K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+9K200899Quantib AI NodeQuantib B.V.20200—
+9K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+9K190868Cleerly LabsCleerly, Inc.20197—
+9K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+9K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+9K183012vascuCAPElucid Bioimaging, Inc.20182—
+9K183037Monaco RTP SystemElekta, Inc.201856
+9K173863Ez3D-i /E3Ewoosoft Co., Ltd.20180—
+9K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+9K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+9K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+9K142647mint LesionMint Medical GmbH201523
+9K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+9K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+9K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+9K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+9K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+10K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+10K252571mdprostateMediaire GmbH20260—
+10K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+10K260528OncoStudioOncosoft. Inc.,20260—
+10K253690LungMapsSiemens Healthineers AG20260—
+10K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+10K253078ART.1-USSeetreat Pty, Ltd.20260—
+10K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+10K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+10K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+10K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+10K251577Laia XRAugmented Reality Software S.L.20260—
+10K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+10K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+10K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+10K252539Tempus PixelArterys, Inc.20250—
+10K250160AnkyrasMentice Spain S.L.20250—
+10K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+10K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+10K240094LumiNE US; LumiAugmedit B.V.20240—
+10K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+10K233925Relu CreatorRelu BV20246—
+10K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+10K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+10K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+10K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+10K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+10K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+10K223774Contour ProtégéAIMim Software, Inc.20233—
+10K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+10K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—