510(k) Report

Devices descending from K052379

353 later devices reach Mim 3.5 (Circa) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+7K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+7K203669Mobius3DVarian Medical Systems, Inc.20213—
+7K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+7K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+7K192437Arterys MICAArterys, Inc.20202—
+7K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+7K192455Merge PACSMerge Healthcare Incorporated201904
+7K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+7K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+7K183248Synapse Enterprise Viewer Version 1.0Fujifilm Corporation20190—
+7K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+7K183034MOSAIQ Oncology Information SystemElekta, Inc.2018122
+7K181892Ziostation2Ziosoft, Inc.20181—
+7K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+7K181185Change Healthcare Enterprise ViewerChange Healthcare Canada Company201802
+7K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+7K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+7K162655StealthConnect Remote Viewing, Planning and Collaboration SystemMedtronic Navigation, Inc.20170—
+7K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+7K162468ClearCheckRadformation20164—
+7K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+7K151233MonacoImpac Medical Systems, Inc.201569
+7K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+8K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+8K253835AffinityHermes Medical Solutions AB20260—
+8K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation20260—
+8K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+8K253270Contour ProtégéAI+Mim Software, Inc.20260—
+8K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+8K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+8K252362GBrain MRIGalileo Cds, Inc.20250—
+8K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+8K243301MapRTVision Rt, Ltd.20250—
+8K250099Mobius3D (4.1)Varian Medical Systems20250—
+8K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+8K242925MR Contour DLGE Healthcare20250—
+8K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+8K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+8K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+8K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+8K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+8K233634TeleScanBb Imaging20230—
+8K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+8K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+8K223834AccuCheckManteia Technologies Co., Ltd.20231—
+8K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+8K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+8K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+8K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+8K203744Arterys MICAArterys, Inc.20221—
+8K203172MOSAIQ Oncology Information SystemElekta Solutions AB202081
+8K201948AcroDTI VisualizerAcroviz, Inc.20200—
+8K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+8K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+8K200315Ziostation2Ziosoft, Inc.20200—
+8K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+8K191384RayCare 2.3RaySearch Laboratories AB (PUBL)20192—
+8K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+8K183037Monaco RTP SystemElekta, Inc.201856
+8K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+8K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+8K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+8K142647mint LesionMint Medical GmbH201523
+9K260528OncoStudioOncosoft. Inc.,20260—
+9K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+9K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+9K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+9K250696AccuCheckManteia Technologies Co., Ltd.20250—
+9K252539Tempus PixelArterys, Inc.20250—
+9K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+9K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—
+9K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+9K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A.20243—
+9K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+9K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+9K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+9K223229MOSAIQ® OIS (Oncology Information System)Elekta Solutions AB202304
+9K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+9K220929ExcelsiorMerit Cro, Inc.20220—
+9K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+9K211760Panther OISProwess, Inc.20210—
+9K210645RayStation 10.1RaySearch Laboratories AB (PUBL)202156
+9K202229AI MetricsAi Metrics, LLC20200—
+9K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+9K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+9K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+9K200899Quantib AI NodeQuantib B.V.20200—
+9K200487RayCare 3.1RaySearch Laboratories AB (PUBL)202015
+9K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+9K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+9K190178Monaco RTP SystemElekta, Inc.201945
+9K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+9K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+10K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+10K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+10K252571mdprostateMediaire GmbH20260—
+10K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+10K253690LungMapsSiemens Healthineers AG20260—
+10K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—