510(k) Report

Devices descending from K021099

77 later devices reach Rex, Version 1.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030457Rex, Version 3.0Pointdx, Inc.200376—
+2K033955RTISTMirada Solutions, Ltd.200475—
+3K101228Mirada XDMirada Medical, Ltd.201070—
+3K081215VoluminaKjaya Medical, LLC20080—
+3K061418QuantivaTomographix IP, Ltd.20060—
+3K060378VITREA2 Version 3.8.1Vital Images, Inc.20061—
+4K220779XDMirada Medical, Ltd.20220—
+4K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+4K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+4K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+4K120161Alphapoint Imaging SoftwareRadlogics, Inc.20120—
+4K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+4K102687Mirada RTMirada Medical, Ltd.201037—
+5K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+5K211655aPROMISEExini Diagnostics AB20211—
+5K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+5K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+5K130393Mirada RTXMirada Medical, Ltd.201336—
+6K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+6K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+6K220590aPROMISE XExini Diagnostics AB20220—
+6K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+6K202700ART-PlanTherapanacea20215—
+6K200323AutoContourRadformation, Inc.20207—
+6K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+6K190232Synapse PACSFujifilm Corporation2019311
+6K181572Workflow BoxMirada Medical, Ltd.201825—
+6K173475Merge PACSMerge Healthcare Incorporated201712
+6K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+6K163668SuitestensaEbit Srl20170—
+6K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+7K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+7K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+7K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+7K220813Art-PlanTherapanacea20224—
+7K212915MVision AI SegmentationMVision AI20221—
+7K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+7K202928DV. TargetDeepvoxel, Inc.20210—
+7K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+7K193252Contour ProtegeAIMim Software, Inc.20206—
+7K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+7K192455Merge PACSMerge Healthcare Incorporated201904
+7K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+8K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+8K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+8K230023ART-PlanTherapanacea Sas20233—
+8K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+8K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+8K210632Contour ProtegeAIMim Software, Inc.20215—
+8K151233MonacoImpac Medical Systems, Inc.201569
+9K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+9K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+9K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+9K232479ART-PlanTherapanacea20232—
+9K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+9K213976Contour ProtégéAIMim Software, Inc.20224—
+9K183037Monaco RTP SystemElekta, Inc.201856
+10K260528OncoStudioOncosoft. Inc.,20260—
+10K253078ART.1-USSeetreat Pty, Ltd.20260—
+10K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+10K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+10K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+10K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+10K223774Contour ProtégéAIMim Software, Inc.20233—
+10K190178Monaco RTP SystemElekta, Inc.201945
+11K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+11K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+11K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+11K231765Contour ProtégéAIMim Software, Inc.20232—
+11K202789Monaco Rtp SystemElekta Solutions AB20213—
+12K250035Contour ProtégéAI+Mim Software, Inc.20251—
+12K213787Monaco RTP SystemElekta Solutions AB20222—
+13K253270Contour ProtégéAI+Mim Software, Inc.20260—
+13K223233Monaco RTP SystemElekta Solutions AB20231—
+14K252002Monaco RTP System (6.3)Elekta Solutions AB20260—