510(k) Report

Devices descending from K972903

353 later devices reach Imatron Ultra Access Workstation with Cardiac Software Extensions through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K241312TeraRecon Cardiac.Chambers.MR (1.0.0)Terarecon,Inc.20240—
+6K241847Imbio PHA (4.0.0)Imbio, Inc.20240—
+6K240620Cube NavigatorMedical Templates AG20240—
+6K231662Aid-UIaid20241—
+6K223424Spine Auto ViewsGE Medical Systems SCS20230—
+6K223396Rapid RV/LVIschemaview, Inc.20231—
+6K221796Cyware 4H and Cysart 4HAbys Medical20221—
+6K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+6K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+6K221100Viz RV/LVViz. Ai, Inc.20224—
+6K220624AI4CMR v1.0Ai4medimaging Medical Solutions S.A.20222—
+6K221463ElucidVivo A.3Elucid Bioimaging, Inc.20221—
+6K220590aPROMISE XExini Diagnostics AB20220—
+6K213944HealthOSTNanoxai, Ltd.20221—
+6K212624EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemEver Fortune.Ai, Co., Ltd.20223—
+6K212896Visible Patient SuiteVisible Patient, Sas20213—
+6K212777Collaboration LivePhilips Ultrasound, Inc.20211—
+6K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+6K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+6K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+6K200315Ziostation2Ziosoft, Inc.20200—
+6K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+6K191530StoneCheckerImaging Biometrics, LLC20191—
+6K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+6K191262aBSIExini Diagnostics AB20192—
+6K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+6K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+6K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+6K180867AmCAD-UOAmcad Biomed Corporation20180—
+6K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+6K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+6K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+6K173444Quantitative Total Extensible Imaging (QTxI)Aiq Solutions, Inc.20181—
+6K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+6K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—
+6K163232Vitrea ViewVital Images, Inc.20177—
+6K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+6K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+6K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+6K132532Syngo.Plaza VB10ASiemens AG Healthcare2013811
+6K1134423DIShina Systems, Ltd.20120—
+7K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+7K252084AI4CMR v2.0Ai4medimaging Medical Solutions S.A.20260—
+7K250039HPACSHealthhub20250—
+7K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+7K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+7K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+7K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+7K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+7K244012Mosaic (V1.0.1)Navier Medical20250—
+7K243378Rapid MLSIschemaview, Inc.20250—
+7K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+7K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+7K243069Lumys (V1)Intradys20250—
+7K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+7K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+7K233998TRAQinform IQAiq Global, Inc.20240—
+7K241302SonoSyncSamsung Medison Co., Ltd.20240—
+7K233457RUSHutom, Inc.20240—
+7K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+7K232613CT CardiomegalyInnolitics, LLC20241—
+7K233080HealthFLDNano-X AI, Ltd.20240—
+7K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+7K230534BriefCase-QuantificationAidoc Medical, Ltd.20233—
+7K231149qXR-CTRQure.Ai Technologies20230—
+7K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+7K220039AutoSegAi Medic, Inc.20221—
+7K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+7K220727inHEART MODELSInheart, Sas20221—
+7K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+7K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20212—
+7K202084DeepLook PRECISEDeeplook, Inc.20210—
+7K201948AcroDTI VisualizerAcroviz, Inc.20200—
+7K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+7K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+7K192277CardIQ FlowGE Medical Systems SCS20200—
+7K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+7K190764SurgicalARMedivis, Inc.20196—
+7K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+7K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc.20180—
+7K180563syngo.plazaSiemens Healthcare GmbH20180—
+7K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+7K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+7K142750JiveXVisus Technology Transfer GmbH20156—
+8K261210Cleerly PlaqueCleerly, Inc.20260—
+8K260588Cleerly LABSCleerly, Inc.20260—
+8K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+8K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+8K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—
+8K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+8K243859PRAEVAorta®2Nurea20250—
+8K243779Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill Health20250—
+8K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+8K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+8K241112BriefCase-QuantificationAidoc Medical, Ltd.20241—
+8K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+8K231683inHEART ModelsInheart, Sas20240—
+8K230249IkshanaImmersivetouch20231—
+8K221870CarnaLife HoloMedapp S.A.20230—
+8K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—