510(k) Report

Devices descending from K010726

401 later devices reach Modification to Mirage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K253962ClearCheck (RADCC V2.7)Radformation, Inc.20260—
+7K260479TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202611
+7K253532TruSPECT Processing StationSpectrum Dynamics Medical, Ltd.20250—
+7K252922Neosoma Brain MetsNeosoma, Inc.20250—
+7K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+7K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+7K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+7K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+7K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+7K243069Lumys (V1)Intradys20250—
+7K250416GBrain MRIGalileo Cds, Inc.20251—
+7K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+7K241364Hybrid Viewer (00859873006189)Hermes Medical Solutions AB20241—
+7K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+7K241837Limbus ContourLimbus Ai, Inc.20240—
+7K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+7K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+7K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+7K231765Contour ProtégéAIMim Software, Inc.20232—
+7K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+7K231185MapRTVision Rt, Ltd.20231—
+7K230082Auto SegmentationGe Medical Systems, LLC20231—
+7K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+7K221706AccuContourManteia Technologies Co., Ltd.20232—
+7K220630TorchTM SoftwareVoximetry, Incorporated20221—
+7K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+7K220767TeleScanBb Imaging20221—
+7K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+7K213628VBrainVysioneer, Inc.20210—
+7K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+7K212116VBrain-OARVysioneer, Inc.20211—
+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—
+7K201103Xeleris V Processing and Review SystemsGE Healthcare20204—
+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
+7K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20183—
+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—
+7K171719Hybrid3DHermes Medical Solutions AB20175—
+7K163394Hybrid3DHermes Medical Solutions AB20176—
+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—
+8K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+8K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+8K252477Hybrid Viewer (00859873006240)Hermes Medical Solutions AB20250—
+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—
+8K250035Contour ProtégéAI+Mim Software, Inc.20251—
+8K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+8K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+8K233908cNeuro cDATCombinostics OY20240—
+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—
+8K221984InterView XP; InterView FUSIONMediso Medical Imaging Systems, Lttd.20230—
+8K221680Xeleris V Processing and Review SystemGE Healthcare20231—
+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
+8K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20192—
+8K191384RayCare 2.3RaySearch Laboratories AB (PUBL)20192—
+8K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+8K183037Monaco RTP SystemElekta, Inc.201856