510(k) Report

Devices descending from K120487

52 later devices reach Vantage Titan 3T through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+1K132160Vantage Titan 3TToshibamedical Systems Corporation201337—
+2K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+2K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+2K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+2K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+2K143008Vantage Titan 3TToshibamedical Systems Corporation201536—
+3K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+3K191128Vantage Titan 3T, MRT-3010, V2.5Canon Medical Systems Corporation201902
+3K152371Vantage Titan 3TToshibamedical Systems Corporation2015321
+3K150427Vantage Titan 1.5T, V3.1, MRT-1510Toshibamedical Systems Corporation201518—
+4K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+4K172878Vantage Titan 3T, MRT-3010/A7, M-Power GXToshiba Medical Systems Corporation, Japan201701
+4K162183Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation201631—
+4K160632Vantage Titan 1.5T, MRT-1510, V3.6 SoftwareToshibamedical Systems Corporation201617—
+5K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+5K173382Vantage Galan 3T, V4.6Toshibamedical Systems Corporation201813—
+5K170412Vantage Titan 1.5T, MRT-1510, M-Power GXToshibamedical Systems Corporation2017162
+6K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+6K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+6K182282Vantage Orian 1.5T, MRT-1550, V4.5Canon Medical Systems Corporation201814—
+6K181593Vantage Galan 3T, MRT-3020/A7, V5.0Canon Medical Systems Corporation201812—
+7K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+7K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+7K193021Vantage Orian 1.5T, MRT-1550, V6.0Canon Medical Systems Corporation202012—
+7K192574Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20209—
+7K192506Vantage Galan 3T, MRT-3020, V6.0Canon Medical Systems Corporation20200—
+7K191662Vantage Orian 1.5T, MRT-1550, V4.5Canon Medical Systems Corporation20190—
+7K183657Vantage Galan 3T, MRT-3020/A9, V5.0Canon Medical Systems Corporation20190—
+8K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+8K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+8K203323Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20211—
+8K203553Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation202161
+8K202767Vantage Orian 1.5T, MRT-1550, V6.0Canon Medical Systems Corporation20211—
+8K202210Vantage Orian 1.5T, MRT-1550, V6.0Canon Medical Systems Corporation20207—
+8K193097Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20203—
+9K212056Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20215—
+9K211633Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20216—
+9K211037Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20210—
+9K210340Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20210—
+9K203053Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20200—
+10K220192Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20224—
+10K213305Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20215—
+11K222387Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20223—
+11K220335Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20224—
+12K230355Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation202322
+12K222968Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation202232
+13K241496Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20241—
+13K240238Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20242—
+14K250901Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for…Canon Medical Systems Corporation20251—
+14K243335Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation202501
+15K253625Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for…Canon Medical Systems Corporation20260—