510(k) Report

Devices descending from K973010

386 later devices reach Realtime 3D Diagnostic Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+8K221796Cyware 4H and Cysart 4HAbys Medical20221—
+8K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+8K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+8K221463ElucidVivo A.3Elucid Bioimaging, Inc.20221—
+8K220590aPROMISE XExini Diagnostics AB20220—
+8K213944HealthOSTNanoxai, Ltd.20221—
+8K212896Visible Patient SuiteVisible Patient, Sas20213—
+8K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+8K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+8K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+8K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+8K200315Ziostation2Ziosoft, Inc.20200—
+8K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+8K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+8K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+8K191530StoneCheckerImaging Biometrics, LLC20191—
+8K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+8K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+8K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+8K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+8K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+8K190764SurgicalARMedivis, Inc.20196—
+8K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+8K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+8K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+8K180867AmCAD-UOAmcad Biomed Corporation20180—
+8K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+8K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+8K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+8K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+8K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+8K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+8K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+8K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+8K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+8K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+8K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+8K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+9K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+9K250039HPACSHealthhub20250—
+9K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+9K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+9K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+9K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+9K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+9K244012Mosaic (V1.0.1)Navier Medical20250—
+9K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+9K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+9K243069Lumys (V1)Intradys20250—
+9K243769QFR (3.0)Qfr Solutions BV20250—
+9K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+9K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+9K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+9K241440HealthCCSngNano-X AI, Ltd.20240—
+9K233457RUSHutom, Inc.20240—
+9K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+9K233080HealthFLDNano-X AI, Ltd.20240—
+9K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+9K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+9K230249IkshanaImmersivetouch20231—
+9K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+9K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+9K230112CAC SoftwareImbio, Inc.20230—
+9K221870CarnaLife HoloMedapp S.A.20230—
+9K230223iCAC DeviceBunkerhill, Inc.20236—
+9K213215VSI HoloMedicineApoqlar GmbH20222—
+9K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+9K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+9K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+9K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+9K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+9K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+9K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+9K202084DeepLook PRECISEDeeplook, Inc.20210—
+9K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+9K201948AcroDTI VisualizerAcroviz, Inc.20200—
+9K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+9K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+9K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+9K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+9K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+9K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+9K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+9K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+9K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+9K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+9K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+9K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+9K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+9K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+10K261210Cleerly PlaqueCleerly, Inc.20260—
+10K260588Cleerly LABSCleerly, Inc.20260—
+10K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+10K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+10K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—
+10K260166Bunkerhill Contrast CACBunkerHill Health20260—
+10K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+10K251577Laia XRAugmented Reality Software S.L.20260—
+10K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—