510(k) Report

Devices descending from K982004

274 later devices reach CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K223774Contour ProtégéAIMim Software, Inc.20233—
+10K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+10K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+10K220929ExcelsiorMerit Cro, Inc.20220—
+10K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+10K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+10K212896Visible Patient SuiteVisible Patient, Sas20213—
+10K202789Monaco Rtp SystemElekta Solutions AB20213—
+10K202229AI MetricsAi Metrics, LLC20200—
+10K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+10K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+10K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+10K200899Quantib AI NodeQuantib B.V.20200—
+10K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+10K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+10K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+10K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+11K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+11K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+11K252571mdprostateMediaire GmbH20260—
+11K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+11K253690LungMapsSiemens Healthineers AG20260—
+11K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+11K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+11K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+11K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+11K233457RUSHutom, Inc.20240—
+11K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+11K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+11K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+11K231765Contour ProtégéAIMim Software, Inc.20232—
+11K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+11K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+11K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+11K213787Monaco RTP SystemElekta Solutions AB20222—
+11K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+11K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+11K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+12K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+12K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+12K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+12K250035Contour ProtégéAI+Mim Software, Inc.20251—
+12K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+12K241211CoLumboSmart Soft Healthcare20242—
+12K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+12K223233Monaco RTP SystemElekta Solutions AB20231—
+12K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+12K220497CoLumboSmart Soft Healthcare AD20226—
+12K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+12K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+13K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+13K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+13K253270Contour ProtégéAI+Mim Software, Inc.20260—
+13K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+13K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+13K250367CoLumboXSmart Soft Healthcare AD20250—
+13K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+13K240793MSKaiMskai20240—
+13K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+13K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+13K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+13K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+14K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+14K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+14K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+14K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+14K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+15K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+15K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+15K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+16K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+16K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+17K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+18K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—