510(k) Report

Devices descending from K080038

61 later devices reach Vantage Titan, Model MRT-1504/S3 through their predicates, nearest generation first.

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