510(k) Report

Devices descending from K000395

207 later devices reach Einstein Processing and Review Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+7K252477Hybrid Viewer (00859873006240)Hermes Medical Solutions AB20250—
+7K250800UroNav 4Philips DS North America, LLC20250—
+7K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+7K233908cNeuro cDATCombinostics OY20240—
+7K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+7K230023ART-PlanTherapanacea Sas20233—
+7K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+7K221984InterView XP; InterView FUSIONMediso Medical Imaging Systems, Lttd.20230—
+7K221680Xeleris V Processing and Review SystemGE Healthcare20231—
+7K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+7K220590aPROMISE XExini Diagnostics AB20220—
+7K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+7K210632Contour ProtegeAIMim Software, Inc.20215—
+7K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+7K203235VBrainVysioneer, Inc.20214—
+7K202882AffinityHermes Medical Solutions AB20201—
+7K202392SIR-Spheres Microspheres Activity Calculator (SMAC)Sirtex Medical US Holdings, Inc.20200—
+7K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+7K193152AffinityHermes Medical Solutions AB20200—
+7K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+7K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+7K190232Synapse PACSFujifilm Corporation2019311
+7K190379MIM on LinuxMim Software, Inc.201914—
+7K182419Centricity Universal ViewerGE Healthcare201828
+7K173475Merge PACSMerge Healthcare Incorporated201712
+7K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+7K163668SuitestensaEbit Srl20170—
+7K170521Trinity/3D Prostate SuiteKoelis20170—
+7K151233MonacoImpac Medical Systems, Inc.201569
+7K141881RapidresultsRamsoft, Inc.20145—
+8K253835AffinityHermes Medical Solutions AB20260—
+8K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+8K252922Neosoma Brain MetsNeosoma, Inc.20250—
+8K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+8K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+8K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+8K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+8K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+8K241350Clarify DLGe Medical Systems Israel, Functional Imaging20250—
+8K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+8K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+8K232479ART-PlanTherapanacea20232—
+8K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+8K230082Auto SegmentationGe Medical Systems, LLC20231—
+8K221706AccuContourManteia Technologies Co., Ltd.20232—
+8K223800MIM – Additional TracersMim Software, Inc.20231—
+8K220630TorchTM SoftwareVoximetry, Incorporated20221—
+8K222476OmegaAI Image ViewerRamsoft, Inc.20223—
+8K220256MIM-AblationMim Software, Inc.20224—
+8K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+8K213976Contour ProtégéAIMim Software, Inc.20224—
+8K213628VBrainVysioneer, Inc.20210—
+8K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+8K212116VBrain-OARVysioneer, Inc.20211—
+8K211312Universal ViewerGE Healthcare202112
+8K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+8K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+8K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+8K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+8K192455Merge PACSMerge Healthcare Incorporated201904
+8K183037Monaco RTP SystemElekta, Inc.201856
+8K163158MEDSYNAPSE Zero Footprint ViewerMedsynaptic Private, Ltd.20160—
+9K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+9K260528OncoStudioOncosoft. Inc.,20260—
+9K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+9K253078ART.1-USSeetreat Pty, Ltd.20260—
+9K254237Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl.20260—
+9K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+9K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+9K253639ViewGE Healthcare20260—
+9K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+9K242925MR Contour DLGE Healthcare20250—
+9K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+9K241546aiCockpit AI ViewerFovia, Inc.20250—
+9K242362Lightning ViewerNexsys Electronics Inc. Dba Medweb20240—
+9K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+9K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+9K232514MIM – Dose AnalysisMim Software, Inc.20240—
+9K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+9K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+9K223774Contour ProtégéAIMim Software, Inc.20233—
+9K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+9K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+9K190178Monaco RTP SystemElekta, Inc.201945
+10K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+10K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+10K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+10K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—
+10K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A.20243—
+10K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+10K231765Contour ProtégéAIMim Software, Inc.20232—
+10K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+10K202789Monaco Rtp SystemElekta Solutions AB20213—
+11K251883MIM – LesionID ProMim Software, Inc.20250—
+11K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH20252—
+11K250035Contour ProtégéAI+Mim Software, Inc.20251—
+11K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+11K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+11K213787Monaco RTP SystemElekta Solutions AB20222—