510(k) Report

Devices descending from K101749

76 later devices reach Syngo Trued Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173542Arterys Oncology DLArterys, Inc.20185—
+1K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+1K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+1K123920Syngo.ViaSiemens AG Medical Solutions201363—
+2K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+2K210831OnQ NeuroCortechs Labs, Inc.20213—
+2K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+2K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+2K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+2K182034Arterys MICAArterys, Inc.20183—
+2K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+2K150843syngo®.via (version VB10A)Siemens AG201546—
+2K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+3K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+3K250416GBrain MRIGalileo Cds, Inc.20251—
+3K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+3K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+3K192437Arterys MICAArterys, Inc.20202—
+3K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+3K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+3K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+3K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+3K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+3K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+3K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+4K252362GBrain MRIGalileo Cds, Inc.20250—
+4K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+4K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+4K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+4K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+4K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+4K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+4K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+4K203744Arterys MICAArterys, Inc.20221—
+4K201948AcroDTI VisualizerAcroviz, Inc.20200—
+4K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+4K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+4K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+4K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+4K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+5K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+5K252539Tempus PixelArterys, Inc.20250—
+5K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+5K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+5K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+5K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+5K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+5K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+5K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+5K200899Quantib AI NodeQuantib B.V.20200—
+5K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+5K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+6K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+6K252571mdprostateMediaire GmbH20260—
+6K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+6K253690LungMapsSiemens Healthineers AG20260—
+6K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+6K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+6K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+6K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+6K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+6K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+6K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+6K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+7K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+7K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+7K241211CoLumboSmart Soft Healthcare20242—
+7K220497CoLumboSmart Soft Healthcare AD20226—
+7K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+8K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+8K250367CoLumboXSmart Soft Healthcare AD20250—
+8K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+8K240793MSKaiMskai20240—
+8K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+8K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+9K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—