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
+8K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+8K213215VSI HoloMedicineApoqlar GmbH20222—
+8K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+8K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+8K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+8K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+8K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+8K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+8K200132AshvinsMedicalcommunications GmbH202001
+8K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+8K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+8K162008JiveXVisus Technology Transfer GmbH20164—
+9K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+9K252571mdprostateMediaire GmbH20260—
+9K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+9K253690LungMapsSiemens Healthineers AG20260—
+9K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+9K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+9K251577Laia XRAugmented Reality Software S.L.20260—
+9K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+9K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+9K242203BriefCase-QuantificationAidoc Medical, Ltd.20240—
+9K240094LumiNE US; LumiAugmedit B.V.20240—
+9K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+9K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+9K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+9K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+9K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+9K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+9K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+9K181964JiveXVisus Health IT GmbH20183—
+10K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+10K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+10K241211CoLumboSmart Soft Healthcare20242—
+10K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+10K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+10K220497CoLumboSmart Soft Healthcare AD20226—
+10K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+10K200703JiveXVisus Health IT GmbH20202—
+11K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+11K250367CoLumboXSmart Soft Healthcare AD20250—
+11K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+11K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+11K240793MSKaiMskai20240—
+11K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+11K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+11K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+11K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+11K212321JiveX (Model Number / Release: 5.3)Visus Health IT GmbH20211—
+12K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+12K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+12K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+12K231041JiveX (Model Number / Release: 5.4)Visus Health IT GmbH20230—