510(k) Report

Devices descending from K051673

192 later devices reach Xeleris 2 Processing and Review Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K203235VBrainVysioneer, Inc.20214—
+5K202882AffinityHermes Medical Solutions AB20201—
+5K202392SIR-Spheres Microspheres Activity Calculator (SMAC)Sirtex Medical US Holdings, Inc.20200—
+5K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+5K193152AffinityHermes Medical Solutions AB20200—
+5K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+5K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+5K190232Synapse PACSFujifilm Corporation2019311
+5K190379MIM on LinuxMim Software, Inc.201914—
+5K182419Centricity Universal ViewerGE Healthcare201828
+5K173475Merge PACSMerge Healthcare Incorporated201712
+5K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+5K163668SuitestensaEbit Srl20170—
+5K170521Trinity/3D Prostate SuiteKoelis20170—
+5K151233MonacoImpac Medical Systems, Inc.201569
+5K141881RapidresultsRamsoft, Inc.20145—
+6K253835AffinityHermes Medical Solutions AB20260—
+6K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+6K252922Neosoma Brain MetsNeosoma, Inc.20250—
+6K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+6K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+6K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+6K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+6K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+6K241350Clarify DLGe Medical Systems Israel, Functional Imaging20250—
+6K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+6K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+6K232479ART-PlanTherapanacea20232—
+6K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+6K230082Auto SegmentationGe Medical Systems, LLC20231—
+6K221706AccuContourManteia Technologies Co., Ltd.20232—
+6K223800MIM – Additional TracersMim Software, Inc.20231—
+6K220630TorchTM SoftwareVoximetry, Incorporated20221—
+6K222476OmegaAI Image ViewerRamsoft, Inc.20223—
+6K220256MIM-AblationMim Software, Inc.20224—
+6K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+6K213976Contour ProtégéAIMim Software, Inc.20224—
+6K213628VBrainVysioneer, Inc.20210—
+6K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+6K212116VBrain-OARVysioneer, Inc.20211—
+6K211312Universal ViewerGE Healthcare202112
+6K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+6K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+6K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+6K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+6K192455Merge PACSMerge Healthcare Incorporated201904
+6K183037Monaco RTP SystemElekta, Inc.201856
+6K163158MEDSYNAPSE Zero Footprint ViewerMedsynaptic Private, Ltd.20160—
+7K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+7K260528OncoStudioOncosoft. Inc.,20260—
+7K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+7K253078ART.1-USSeetreat Pty, Ltd.20260—
+7K254237Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl.20260—
+7K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+7K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+7K253639ViewGE Healthcare20260—
+7K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+7K242925MR Contour DLGE Healthcare20250—
+7K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+7K241546aiCockpit AI ViewerFovia, Inc.20250—
+7K242362Lightning ViewerNexsys Electronics Inc. Dba Medweb20240—
+7K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+7K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+7K232514MIM – Dose AnalysisMim Software, Inc.20240—
+7K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+7K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+7K223774Contour ProtégéAIMim Software, Inc.20233—
+7K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+7K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+7K190178Monaco RTP SystemElekta, Inc.201945
+8K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+8K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+8K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+8K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—
+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—
+8K231765Contour ProtégéAIMim Software, Inc.20232—
+8K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+8K202789Monaco Rtp SystemElekta Solutions AB20213—
+9K251883MIM – LesionID ProMim Software, Inc.20250—
+9K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH20252—
+9K250035Contour ProtégéAI+Mim Software, Inc.20251—
+9K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+9K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+9K213787Monaco RTP SystemElekta Solutions AB20222—
+10K261306AI Contouring (VA10A)Varian Medical Systems20260—
+10K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+10K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+10K253270Contour ProtégéAI+Mim Software, Inc.20260—
+10K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+10K223233Monaco RTP SystemElekta Solutions AB20231—
+11K252002Monaco RTP System (6.3)Elekta Solutions AB20260—