510(k) Report

Devices descending from K953255

383 later devices reach Nuquest Nuclear Medicine Computer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K260479TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202611
+10K252922Neosoma Brain MetsNeosoma, Inc.20250—
+10K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+10K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+10K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+10K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+10K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+10K243069Lumys (V1)Intradys20250—
+10K250416GBrain MRIGalileo Cds, Inc.20251—
+10K250035Contour ProtégéAI+Mim Software, Inc.20251—
+10K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+10K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+10K241837Limbus ContourLimbus Ai, Inc.20240—
+10K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+10K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+10K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+10K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+10K231185MapRTVision Rt, Ltd.20231—
+10K230082Auto SegmentationGe Medical Systems, LLC20231—
+10K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20231—
+10K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+10K221706AccuContourManteia Technologies Co., Ltd.20232—
+10K220630TorchTM SoftwareVoximetry, Incorporated20221—
+10K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+10K220767TeleScanBb Imaging20221—
+10K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+10K213628VBrainVysioneer, Inc.20210—
+10K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+10K212116VBrain-OARVysioneer, Inc.20211—
+10K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+10K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+10K203669Mobius3DVarian Medical Systems, Inc.20213—
+10K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+10K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+10K192437Arterys MICAArterys, Inc.20202—
+10K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+10K192455Merge PACSMerge Healthcare Incorporated201904
+10K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+10K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+10K183248Synapse Enterprise Viewer Version 1.0Fujifilm Corporation20190—
+10K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+10K183034MOSAIQ Oncology Information SystemElekta, Inc.2018122
+10K181892Ziostation2Ziosoft, Inc.20181—
+10K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+10K181185Change Healthcare Enterprise ViewerChange Healthcare Canada Company201802
+10K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+10K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+10K162655StealthConnect Remote Viewing, Planning and Collaboration SystemMedtronic Navigation, Inc.20170—
+10K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+10K162468ClearCheckRadformation20164—
+10K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+10K151233MonacoImpac Medical Systems, Inc.201569
+10K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+11K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+11K253835AffinityHermes Medical Solutions AB20260—
+11K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation20260—
+11K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+11K253270Contour ProtégéAI+Mim Software, Inc.20260—
+11K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+11K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20260—
+11K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+11K252362GBrain MRIGalileo Cds, Inc.20250—
+11K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+11K243301MapRTVision Rt, Ltd.20250—
+11K250099Mobius3D (4.1)Varian Medical Systems20250—
+11K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+11K242925MR Contour DLGE Healthcare20250—
+11K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+11K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+11K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+11K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+11K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+11K233634TeleScanBb Imaging20230—
+11K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+11K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+11K223834AccuCheckManteia Technologies Co., Ltd.20231—
+11K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+11K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+11K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+11K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+11K203744Arterys MICAArterys, Inc.20221—
+11K203172MOSAIQ Oncology Information SystemElekta Solutions AB202081
+11K201948AcroDTI VisualizerAcroviz, Inc.20200—
+11K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+11K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+11K200315Ziostation2Ziosoft, Inc.20200—
+11K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+11K191384RayCare 2.3RaySearch Laboratories AB (PUBL)20192—
+11K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+11K183037Monaco RTP SystemElekta, Inc.201856
+11K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+11K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+11K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+11K142647mint LesionMint Medical GmbH201523
+12K260528OncoStudioOncosoft. Inc.,20260—
+12K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+12K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+12K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+12K250696AccuCheckManteia Technologies Co., Ltd.20250—
+12K252539Tempus PixelArterys, Inc.20250—