510(k) Report

Devices descending from K010259

181 later devices reach Mediface Pacs through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+6K123644Vizion + DRViztek, LLC201333—
+6K102435Beyondimage WorkstationNeusoft Medical Systems Co., Ltd.20100—
+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
+7K170975Televere Digital Imaging SystemTelevere Systems20172—
+7K163539Ez3D-i / E3Ewoosoft Co., Ltd.20161—
+7K152279ViZion DR + WirelessViztek, LLC201527—
+7K141435Opal Chiro, 20/20 P-DR2020 Imaging20140—
+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—
+8K180765Televere Podiatry X-Ray System HFTelevere Systems, Inc.20180—
+8K173863Ez3D-i /E3Ewoosoft Co., Ltd.20180—
+8K172124Televere Podiatry Digital Imaging SystemTelevere Systems20170—
+8K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd.201624—
+8K160810ViZion DR + WirelessViztek, LLC20161—
+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—
+9K202995X-ray Flat Panel Detectors/CareView 3600RFCareray Digital Medical System Co., Ltd.20210—
+9K191645SKR 4000Konica Minolta, Inc.20190—
+9K183037Monaco RTP SystemElekta, Inc.201856
+9K182551Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.201818—
+9K182550Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.201812
+9K170480Models 3543A, 4343A, 2929A and A843BShanghai PZ Medical Technolgoy Co., Ltd.20171—
+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—
+10K2121056543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZFPzmedical Technology Co., Ltd.20210—
+10K201004Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat…Iray Technology Taicang, Ltd.20204—
+10K192512Focus 35C Detector, Trimax 35C DetectorIray Technology Taicang, Ltd.20190—
+10K190178Monaco RTP SystemElekta, Inc.201945
+10K190300BIOK7600W Wireless Flat Panel DetectorBiokinemetrics, Inc.20190—
+10K190311BIOK7600 Flat Panel DetectorBiokinemetrics, Inc.20190—
+10K183422Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20190—
+10K183713Wireless Digital Flat DetectorIray Technology Taicang, Ltd.20199—
+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—
+11K210316Mars 1417X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20213—
+11K202789Monaco Rtp SystemElekta Solutions AB20213—
+11K201043Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)Iray Technology Taicang, Ltd.20207—
+11K200622Focus 43C detector, TRIMAX 43C detectorIray Technology Taicang, Ltd.20200—
+12K250035Contour ProtégéAI+Mim Software, Inc.20251—
+12K221714Flat Panel DetectorIray Technology Taicang, Ltd.20221—
+12K213787Monaco RTP SystemElekta Solutions AB20222—
+12K220668Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20221—
+12K213646Focus HD 35 DetectorIray Technology Taicang, Ltd.20220—
+12K210314Mars1717X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20214—
+13K253270Contour ProtégéAI+Mim Software, Inc.20260—
+13K223233Monaco RTP SystemElekta Solutions AB20231—
+13K222886Mercu 1717VIray Technology Taicang, Ltd.20220—
+13K221345Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20220—
+13K213529Focus HD 43 DetectorIray Technology Taicang, Ltd.20223—
+14K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+14K243556Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)Iray Imaging Technology (Haining) Limited20252—
+15K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—
+15K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) Limited20250—