510(k) Report

Devices descending from K060003

69 later devices reach Excelart Vantage ZGV through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1112514CH Flex SpeederToshiba Medical Systems Coporation, Japan20111—
+1K063361Excelart Vantage Atlas, Model MRT-1503Toshiba America Medical Systems, In.C2006681
+2K121911Octave Speeder SpineToshiba Medical Systems Corporation, Japan20120—
+2K1123664CH Flex SpeederToshiba Medical Systems Coporation, Japan20110—
+2K083014Atlas Speeder Head/Cervical Coil, Model Mjah-137AToshiba America Medical Systems, In.C20081—
+2K080038Vantage Titan, Model MRT-1504/S3Toshiba America Medical Systems, In.C2008612
+2K073081Jet Software for Excelart Vantage Atlas-Z and Atlas-XToshiba America Medical Systems, In.C20070—
+3K121910Octave Speeder HeadToshiba Medical Systems Corporation, Japan20120—
+3K120638Vantage TitanToshibamedical Systems Corporation2012212
+3K112003Vantage Titan HSRToshibamedical Systems Corporation201122—
+3K102489Vantage Titan 3TToshiba Medical Systems Corporation, Japan2011561
+4K18169716ch Foot/ Ankle SPEEDERQuality Electrodynamics, LLC20181—
+4K150427Vantage Titan 1.5T, V3.1, MRT-1510Toshibamedical Systems Corporation201518—
+4K141472Vantage ElanToshiba America Medical Systems, In.C201419—
+4K122613Vantage Titan with Helios Gradient Model MRT-1504/USToshiba America Medical Systems, In.C201203
+4K113093Vantage Titan 3TToshibamedical Systems Corporation2012531
+5K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd.20190—
+5K160632Vantage Titan 1.5T, MRT-1510, V3.6 SoftwareToshibamedical Systems Corporation201617—
+5K120487Vantage Titan 3TToshibamedical Systems Corporation201252—
+6K170412Vantage Titan 1.5T, MRT-1510, M-Power GXToshibamedical Systems Corporation2017162
+6K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+6K132160Vantage Titan 3TToshibamedical Systems Corporation201337—
+7K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+7K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+7K182282Vantage Orian 1.5T, MRT-1550, V4.5Canon Medical Systems Corporation201814—
+7K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+7K172878Vantage Titan 3T, MRT-3010/A7, M-Power GXToshiba Medical Systems Corporation, Japan201701
+7K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+7K143008Vantage Titan 3TToshibamedical Systems Corporation201536—
+8K193021Vantage Orian 1.5T, MRT-1550, V6.0Canon Medical Systems Corporation202012—
+8K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+8K191662Vantage Orian 1.5T, MRT-1550, V4.5Canon Medical Systems Corporation20190—
+8K191128Vantage Titan 3T, MRT-3010, V2.5Canon Medical Systems Corporation201902
+8K152371Vantage Titan 3TToshibamedical Systems Corporation2015321
+9K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+9K202767Vantage Orian 1.5T, MRT-1550, V6.0Canon Medical Systems Corporation20211—
+9K202210Vantage Orian 1.5T, MRT-1550, V6.0Canon Medical Systems Corporation20207—
+9K193097Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20203—
+9K162183Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation201631—
+10K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+10K211633Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20216—
+10K210340Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20210—
+10K203053Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20200—
+10K173382Vantage Galan 3T, V4.6Toshibamedical Systems Corporation201813—
+11K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+11K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+11K213305Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20215—
+11K181593Vantage Galan 3T, MRT-3020/A7, V5.0Canon Medical Systems Corporation201812—
+12K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+12K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+12K220335Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20224—
+12K192574Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20209—
+12K192506Vantage Galan 3T, MRT-3020, V6.0Canon Medical Systems Corporation20200—
+12K183657Vantage Galan 3T, MRT-3020/A9, V5.0Canon Medical Systems Corporation20190—
+13K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+13K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+13K222968Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation202232
+13K203323Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20211—
+13K203553Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation202161
+14K240238Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20242—
+14K212056Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20215—
+14K211037Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20210—
+15K250901Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for…Canon Medical Systems Corporation20251—
+15K220192Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20224—
+16K253625Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for…Canon Medical Systems Corporation20260—
+16K222387Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20223—
+17K230355Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation202322
+18K241496Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20241—
+19K243335Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation202501