510(k) Report

Devices descending from K002531

76 later devices reach Excelart with Pianissimo, Model MRT-1501/P3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023511Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2Toshiba America Medical Systems, In.C2002742
+1K023207Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit)Toshiba America Medical Systems, In.C20020—
+2K032490Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and MRT-1503/P2Toshiba America Medical Systems, In.C2003733
+3K060003Excelart Vantage ZGVToshibamedical Systems Corporation2006691
+3K051763QD Knee/Foot Coil, Model MJQJ-147AToshiba America Medical Systems, In.C20052—
+4K1112514CH Flex SpeederToshiba Medical Systems Coporation, Japan20111—
+4K103185Toshiba 1.5T Extra Large Knee CoilQuality Electrodynamics20111—
+4K063361Excelart Vantage Atlas, Model MRT-1503Toshiba America Medical Systems, In.C2006681
+5K121911Octave Speeder SpineToshiba Medical Systems Corporation, Japan20120—
+5K1123664CH Flex SpeederToshiba Medical Systems Coporation, Japan20110—
+5K112313Toshiba 3T Extra Large Knee CoilQuality Electrodynamics20110—
+5K083014Atlas Speeder Head/Cervical Coil, Model Mjah-137AToshiba America Medical Systems, In.C20081—
+5K080038Vantage Titan, Model MRT-1504/S3Toshiba America Medical Systems, In.C2008612
+5K073081Jet Software for Excelart Vantage Atlas-Z and Atlas-XToshiba America Medical Systems, In.C20070—
+6K121910Octave Speeder HeadToshiba Medical Systems Corporation, Japan20120—
+6K120638Vantage TitanToshibamedical Systems Corporation2012212
+6K112003Vantage Titan HSRToshibamedical Systems Corporation201122—
+6K102489Vantage Titan 3TToshiba Medical Systems Corporation, Japan2011561
+7K18169716ch Foot/ Ankle SPEEDERQuality Electrodynamics, LLC20181—
+7K150427Vantage Titan 1.5T, V3.1, MRT-1510Toshibamedical Systems Corporation201518—
+7K141472Vantage ElanToshiba America Medical Systems, In.C201419—
+7K122613Vantage Titan with Helios Gradient Model MRT-1504/USToshiba America Medical Systems, In.C201203
+7K113093Vantage Titan 3TToshibamedical Systems Corporation2012531
+8K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd.20190—
+8K160632Vantage Titan 1.5T, MRT-1510, V3.6 SoftwareToshibamedical Systems Corporation201617—
+8K120487Vantage Titan 3TToshibamedical Systems Corporation201252—
+9K170412Vantage Titan 1.5T, MRT-1510, M-Power GXToshibamedical Systems Corporation2017162
+9K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+9K132160Vantage Titan 3TToshibamedical Systems Corporation201337—
+10K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+10K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+10K182282Vantage Orian 1.5T, MRT-1550, V4.5Canon Medical Systems Corporation201814—
+10K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+10K172878Vantage Titan 3T, MRT-3010/A7, M-Power GXToshiba Medical Systems Corporation, Japan201701
+10K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+10K143008Vantage Titan 3TToshibamedical Systems Corporation201536—
+11K193021Vantage Orian 1.5T, MRT-1550, V6.0Canon Medical Systems Corporation202012—
+11K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+11K191662Vantage Orian 1.5T, MRT-1550, V4.5Canon Medical Systems Corporation20190—
+11K191128Vantage Titan 3T, MRT-3010, V2.5Canon Medical Systems Corporation201902
+11K152371Vantage Titan 3TToshibamedical Systems Corporation2015321
+12K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+12K202767Vantage Orian 1.5T, MRT-1550, V6.0Canon Medical Systems Corporation20211—
+12K202210Vantage Orian 1.5T, MRT-1550, V6.0Canon Medical Systems Corporation20207—
+12K193097Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20203—
+12K162183Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation201631—
+13K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+13K211633Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20216—
+13K210340Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20210—
+13K203053Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20200—
+13K173382Vantage Galan 3T, V4.6Toshibamedical Systems Corporation201813—
+14K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+14K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+14K213305Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20215—
+14K181593Vantage Galan 3T, MRT-3020/A7, V5.0Canon Medical Systems Corporation201812—
+15K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+15K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+15K220335Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20224—
+15K192574Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20209—
+15K192506Vantage Galan 3T, MRT-3020, V6.0Canon Medical Systems Corporation20200—
+15K183657Vantage Galan 3T, MRT-3020/A9, V5.0Canon Medical Systems Corporation20190—
+16K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+16K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+16K222968Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation202232
+16K203323Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20211—
+16K203553Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation202161
+17K240238Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20242—
+17K212056Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20215—
+17K211037Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20210—
+18K250901Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for…Canon Medical Systems Corporation20251—
+18K220192Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20224—
+19K253625Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for…Canon Medical Systems Corporation20260—
+19K222387Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20223—
+20K230355Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation202322
+21K241496Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20241—
+22K243335Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation202501