510(k) Report

Devices descending from K130749

54 later devices reach Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vascular through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+1K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+1K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+1K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+1K152602Olea Sphere V3.0Olea Medical201617—
+1K150069Fine Structure Analysis (fineSA)Acuitas Medical, Ltd.20150—
+1K133401Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR GeneralSiemens Medical Solutions USA, Inc.201427—
+2K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+2K243681Neuro Insight V1.0Olea Medical S.A.S.20250—
+2K223091CT Perfusion V1.0Olea Medical20230—
+2K223532Olea S.I.A. Neurovascular V1.0Olea Medical20231—
+2K230552MR DWI/FLAIR Measurement V1.0Olea Medical20230—
+2K211059CereFlow™ V1.2Translational Mri, LLC20231—
+2K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+2K223502MR Diffusion Perfusion Mismatch V1.0Olea Medical20230—
+2K212565CoverScan v1Perspectum, Ltd.20221—
+2K203582QUIBIM Precision Prostate (qp-Prostate)Quibim S.L.20211—
+2K201948AcroDTI VisualizerAcroviz, Inc.20200—
+2K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+2K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+2K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+2K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+2K182716Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20191—
+2K173467Advanced Diffusion Analysis (ADA) applicationPhilips Medical Systems Nederland B.V.20170—
+2K170580Carestream Vue PACSCarestream Health, Inc.20171—
+2K151353syngo.MR Neurology, syngo.MR OncologySiemens Medical Solutions USA, Inc.201525—
+2K140897Syngo.MR Neurology, Syngo.MMR GeneralSiemens Medical Solutions USA, Inc.20140—
+3K253794Prostate CoreLucida Medical, Ltd.20260—
+3K252571mdprostateMediaire GmbH20260—
+3K253421Perfusion Measurement Platform v1Quantified Imaging Limited20260—
+3K253690LungMapsSiemens Healthineers AG20260—
+3K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+3K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+3K243680Neurovascular Insight V1.0Olea Medical S.A.S.20250—
+3K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+3K230294CoverScan (CoverScan v1.1)Perspectum20230—
+3K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20210—
+3K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+3K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+3K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+4K241211CoLumboSmart Soft Healthcare20242—
+4K220497CoLumboSmart Soft Healthcare AD20226—
+4K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+4K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+4K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+5K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+5K250367CoLumboXSmart Soft Healthcare AD20250—
+5K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+5K240793MSKaiMskai20240—
+5K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+5K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+5K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+5K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+6K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—