510(k) Report

Devices descending from K071964

287 later devices reach Mim 4.1 (Seastar) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+4K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+4K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+4K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+4K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+4K192424Mobius3DVarian Medical Systems, Inc.20194—
+4K190232Synapse PACSFujifilm Corporation2019311
+4K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+4K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+4K182034Arterys MICAArterys, Inc.20183—
+4K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+4K173475Merge PACSMerge Healthcare Incorporated201712
+4K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+4K163668SuitestensaEbit Srl20170—
+4K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+4K150843syngo®.via (version VB10A)Siemens AG201546—
+4K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+4K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+4K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+4K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+5K253078ART.1-USSeetreat Pty, Ltd.20260—
+5K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+5K253962ClearCheck (RADCC V2.7)Radformation, Inc.20260—
+5K260479TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202611
+5K252922Neosoma Brain MetsNeosoma, Inc.20250—
+5K251883MIM – LesionID ProMim Software, Inc.20250—
+5K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+5K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+5K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+5K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+5K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+5K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+5K250416GBrain MRIGalileo Cds, Inc.20251—
+5K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+5K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+5K241837Limbus ContourLimbus Ai, Inc.20240—
+5K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+5K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+5K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+5K231185MapRTVision Rt, Ltd.20231—
+5K230082Auto SegmentationGe Medical Systems, LLC20231—
+5K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+5K223774Contour ProtégéAIMim Software, Inc.20233—
+5K221706AccuContourManteia Technologies Co., Ltd.20232—
+5K220630TorchTM SoftwareVoximetry, Incorporated20221—
+5K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+5K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+5K213628VBrainVysioneer, Inc.20210—
+5K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+5K212116VBrain-OARVysioneer, Inc.20211—
+5K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+5K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+5K203669Mobius3DVarian Medical Systems, Inc.20213—
+5K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+5K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+5K192437Arterys MICAArterys, Inc.20202—
+5K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+5K192455Merge PACSMerge Healthcare Incorporated201904
+5K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+5K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+5K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+5K181892Ziostation2Ziosoft, Inc.20181—
+5K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+5K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+5K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+5K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+5K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+5K151233MonacoImpac Medical Systems, Inc.201569
+5K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+6K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+6K253835AffinityHermes Medical Solutions AB20260—
+6K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation20260—
+6K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+6K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+6K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+6K252362GBrain MRIGalileo Cds, Inc.20250—
+6K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+6K243301MapRTVision Rt, Ltd.20250—
+6K250099Mobius3D (4.1)Varian Medical Systems20250—
+6K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+6K242925MR Contour DLGE Healthcare20250—
+6K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+6K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+6K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+6K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+6K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+6K231765Contour ProtégéAIMim Software, Inc.20232—
+6K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+6K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+6K223834AccuCheckManteia Technologies Co., Ltd.20231—
+6K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+6K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+6K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+6K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+6K203744Arterys MICAArterys, Inc.20221—
+6K201948AcroDTI VisualizerAcroviz, Inc.20200—
+6K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+6K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+6K200315Ziostation2Ziosoft, Inc.20200—
+6K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962