510(k) Report

Devices descending from K060816

350 later devices reach Mim 4.0 (Neuro through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+6K192437Arterys MICAArterys, Inc.20202—
+6K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+6K192455Merge PACSMerge Healthcare Incorporated201904
+6K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+6K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+6K183248Synapse Enterprise Viewer Version 1.0Fujifilm Corporation20190—
+6K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+6K183034MOSAIQ Oncology Information SystemElekta, Inc.2018122
+6K181892Ziostation2Ziosoft, Inc.20181—
+6K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+6K181185Change Healthcare Enterprise ViewerChange Healthcare Canada Company201802
+6K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+6K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+6K162655StealthConnect Remote Viewing, Planning and Collaboration SystemMedtronic Navigation, Inc.20170—
+6K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+6K162468ClearCheckRadformation20164—
+6K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+6K151233MonacoImpac Medical Systems, Inc.201569
+6K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+7K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+7K253835AffinityHermes Medical Solutions AB20260—
+7K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation20260—
+7K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+7K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+7K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+7K252362GBrain MRIGalileo Cds, Inc.20250—
+7K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+7K243301MapRTVision Rt, Ltd.20250—
+7K250099Mobius3D (4.1)Varian Medical Systems20250—
+7K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+7K242925MR Contour DLGE Healthcare20250—
+7K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+7K250035Contour ProtégéAI+Mim Software, Inc.20251—
+7K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+7K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+7K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+7K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+7K233634TeleScanBb Imaging20230—
+7K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+7K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+7K223834AccuCheckManteia Technologies Co., Ltd.20231—
+7K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+7K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+7K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+7K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+7K203744Arterys MICAArterys, Inc.20221—
+7K203172MOSAIQ Oncology Information SystemElekta Solutions AB202081
+7K201948AcroDTI VisualizerAcroviz, Inc.20200—
+7K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+7K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+7K200315Ziostation2Ziosoft, Inc.20200—
+7K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+7K191384RayCare 2.3RaySearch Laboratories AB (PUBL)20192—
+7K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+7K183037Monaco RTP SystemElekta, Inc.201856
+7K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+7K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+7K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+7K142647mint LesionMint Medical GmbH201523
+8K260528OncoStudioOncosoft. Inc.,20260—
+8K253270Contour ProtégéAI+Mim Software, Inc.20260—
+8K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+8K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+8K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+8K250696AccuCheckManteia Technologies Co., Ltd.20250—
+8K252539Tempus PixelArterys, Inc.20250—
+8K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+8K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—
+8K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+8K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A.20243—
+8K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+8K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+8K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+8K223229MOSAIQ® OIS (Oncology Information System)Elekta Solutions AB202304
+8K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+8K220929ExcelsiorMerit Cro, Inc.20220—
+8K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+8K211760Panther OISProwess, Inc.20210—
+8K210645RayStation 10.1RaySearch Laboratories AB (PUBL)202156
+8K202229AI MetricsAi Metrics, LLC20200—
+8K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+8K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+8K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+8K200899Quantib AI NodeQuantib B.V.20200—
+8K200487RayCare 3.1RaySearch Laboratories AB (PUBL)202015
+8K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+8K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+8K190178Monaco RTP SystemElekta, Inc.201945
+8K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+8K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+9K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+9K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+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—
+9K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+9K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+9K242992RayCare (2024A SP1)RaySearch Laboratories AB (PUBL)202502