510(k) Report

Devices descending from K992654

670 later devices reach Plug 'N View 3D, Version 1.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+7K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+7K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc.201235
+7K121023Spectrum V.0Intrinsic Medical Imaging20120—
+7K120207VISIAMeVis Medical Solutions AG20120—
+7K110071Cor AnalyzerRcadia Medical Imaging, Ltd.20114—
+7K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+7K083691BonevueMicromri, Inc.20090—
+7K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+7K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+7K072821Vitrea 4DCTVital Images, Inc.2008171
+8K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+8K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+8K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—
+8K260166Bunkerhill Contrast CACBunkerHill Health20260—
+8K252029AI-CVDHeartLung Corporation20250—
+8K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+8K252086DTX Studio AssistNobel Biocare C/O Medicim NV20250—
+8K250662Bunkerhill MACBunkerHill Health20250—
+8K252362GBrain MRIGalileo Cds, Inc.20250—
+8K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+8K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+8K243769QFR (3.0)Qfr Solutions BV20250—
+8K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+8K243229Bunkerhill AVCBunkerHill Health20253—
+8K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+8K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+8K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+8K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+8K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+8K230006AnkyrasMentice Spain S.L.20231—
+8K232479ART-PlanTherapanacea20232—
+8K230249IkshanaImmersivetouch20231—
+8K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+8K221870CarnaLife HoloMedapp S.A.20230—
+8K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+8K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+8K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+8K213215VSI HoloMedicineApoqlar GmbH20222—
+8K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+8K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+8K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+8K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+8K213562DTX Studio Clinic 3.0Nobel Biocare AB20229—
+8K203744Arterys MICAArterys, Inc.20221—
+8K213976Contour ProtégéAIMim Software, Inc.20224—
+8K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+8K202322Sim&SizeSim&Cure20205—
+8K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+8K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+8K200899Quantib AI NodeQuantib B.V.20200—
+8K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+8K190868Cleerly LabsCleerly, Inc.20197—
+8K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+8K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+8K183012vascuCAPElucid Bioimaging, Inc.20182—
+8K183037Monaco RTP SystemElekta, Inc.201856
+8K173863Ez3D-i /E3Ewoosoft Co., Ltd.20180—
+8K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+8K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+8K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+8K142647mint LesionMint Medical GmbH201523
+8K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+8K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+8K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+8K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+8K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+9K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+9K252571mdprostateMediaire GmbH20260—
+9K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+9K260528OncoStudioOncosoft. Inc.,20260—
+9K253690LungMapsSiemens Healthineers AG20260—
+9K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+9K253078ART.1-USSeetreat Pty, Ltd.20260—
+9K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+9K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+9K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+9K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+9K251577Laia XRAugmented Reality Software S.L.20260—
+9K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+9K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+9K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+9K252539Tempus PixelArterys, Inc.20250—
+9K250160AnkyrasMentice Spain S.L.20250—
+9K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+9K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+9K240094LumiNE US; LumiAugmedit B.V.20240—
+9K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+9K233925Relu CreatorRelu BV20246—
+9K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+9K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+9K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+9K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+9K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+9K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+9K223774Contour ProtégéAIMim Software, Inc.20233—
+9K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+9K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+9K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+9K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—