FDA 510(k) Applications Submitted by Toshiba Medical Systems Corporation

FDA 510(k) Number Submission Date Device Name Applicant
K131507 05/24/2013 XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM TOSHIBA MEDICAL SYSTEMS CORPORATION
K122491 08/15/2012 VIAMO SSA-640A V4.0 TOSHIBA MEDICAL SYSTEMS CORPORATION
K133277 10/24/2013 XARIO 100 TOSHIBA MEDICAL SYSTEMS CORPORATION
K133535 11/18/2013 INFX-8000V, V5.30 TOSHIBA MEDICAL SYSTEMS CORPORATION
K133761 12/11/2013 APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0 TOSHIBA MEDICAL SYSTEMS CORPORATION
K123992 12/26/2012 APLIO 500/400/300 V3.0 TOSHIBA MEDICAL SYSTEMS CORPORATION
K150427 02/19/2015 Vantage Titan 1.5T, V3.1, MRT-1510 TOSHIBA MEDICAL SYSTEMS CORPORATION
K152371 08/21/2015 Vantage Titan 3T Toshiba Medical Systems Corporation
K152697 09/21/2015 INFX-8000C, V6.20 TOSHIBA MEDICAL SYSTEMS CORPORATION
K041027 04/21/2004 DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR, MODEL DFP8000D TOSHIBA MEDICAL SYSTEMS CORPORATION
K141459 06/02/2014 APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0 TOSHIBA MEDICAL SYSTEMS CORPORATION
K141741 06/27/2014 AQUILION PRIME, V6.00 TOSHIBA MEDICAL SYSTEMS CORPORATION
K120073 01/10/2012 INFX-8000V WITH TOSHIBA MEDICAL SYSTEMS CORPORATION
K150003 01/02/2015 Aquilion LB, TSX-201A/3, V6.0 TOSHIBA MEDICAL SYSTEMS CORPORATION
K060003 01/03/2006 EXCELART VANTAGE ZGV TOSHIBA MEDICAL SYSTEMS CORPORATION
K170019 01/03/2017 Aquilion Lightning, TSX-036A/1, V8.4 Toshiba Medical Systems Corporation
K170177 01/19/2017 Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 Toshiba Medical Systems Corporation
K090220 01/29/2009 COLON VIEW, MODEL CSCV-001A TOSHIBA MEDICAL SYSTEMS CORPORATION
K170412 02/10/2017 Vantage Titan 1.5T, MRT-1510, M-Power GX Toshiba Medical Systems Corporation
K120487 02/17/2012 VANTAGE TITAN 3T TOSHIBA MEDICAL SYSTEMS CORPORATION
K170490 02/17/2017 Celesteion, PCA-9000A/3 Toshiba Medical Systems Corporation
K090504 02/26/2009 CSBP-001A BODY PERFUSION SYSTEM TOSHIBA MEDICAL SYSTEMS CORPORATION
K120638 03/01/2012 VANTAGE TITAN TOSHIBA MEDICAL SYSTEMS CORPORATION
K160587 03/01/2016 Aquilion ONE (TSX-305A/3) V7.3 Toshiba Medical Systems Corporation
K160632 03/07/2016 Vantage Titan 1.5T, MRT-1510, V3.6 Software TOSHIBA MEDICAL SYSTEMS CORPORATION
K120710 03/08/2012 AQUILION PRIME TOSHIBA MEDICAL SYSTEMS CORPORATION
K130645 03/11/2013 AQUILION PRIME, V5.00 TOSHIBA MEDICAL SYSTEMS CORPORATION
K140651 03/13/2014 CELESTEION, PCA-9000A/2 TOSHIBA MEDICAL SYSTEMS CORPORATION
K170832 03/20/2017 Ultimax-i, DREX-UI80 V1.60 Toshiba Medical Systems Corporation
K130960 04/05/2013 SURESUBTRACTION ORTHO TOSHIBA MEDICAL SYSTEMS CORPORATION
K161009 04/11/2016 Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 TOSHIBA MEDICAL SYSTEMS CORPORATION
K150967 04/13/2015 XIDF-AWS801, Angio Workstation, V6.10 Toshiba Medical Systems Corporation
K151091 04/23/2015 Vitrea Software Toshiba Package, VSTP-001A Toshiba Medical Systems Corporation
K171222 04/26/2017 Vitrea Software Toshiba Package; VSTP-001A Toshiba Medical Systems Corporation
K121553 05/25/2012 AQUILION RXL TOSHIBA MEDICAL SYSTEMS CORPORATION
K151451 05/29/2015 Aplio 500/400/300 Diagnostic Ultrasound System V6.0 TOSHIBA MEDICAL SYSTEMS CORPORATION
K171597 05/31/2017 Vantage Elan 1.5T, V4.0 Toshiba Medical Systems Corporation
K041499 06/07/2004 SSA-770A, APLIO VERSION 5.5 TOSHIBA MEDICAL SYSTEMS CORPORATION
K141541 06/10/2014 XIDF-AWS801, ANGIO WORKSTATION, V5.31 TOSHIBA MEDICAL SYSTEMS CORPORATION
K151673 06/22/2015 Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) TOSHIBA MEDICAL SYSTEMS CORPORATION
K161843 07/05/2016 Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 TOSHIBA MEDICAL SYSTEMS CORPORATION
K151833 07/06/2015 Aquilion Lightning (TSX-035A/2, V7.0) TOSHIBA MEDICAL SYSTEMS CORPORATION
K132160 07/12/2013 VANTAGE TITAN 3T TOSHIBA MEDICAL SYSTEMS CORPORATION
K112003 07/13/2011 VANTAGE TITAN HSR TOSHIBA MEDICAL SYSTEMS CORPORATION
K132222 07/17/2013 AQUILION ONE VISION, V6.0 TOSHIBA MEDICAL SYSTEMS CORPORATION
K172276 07/28/2017 Xario 200 Diagnostic Ultrasound System V6.0 Toshiba Medical Systems Corporation
K162155 08/02/2016 Xario 200 Diagnostic Ultrasound System V5.0 TOSHIBA MEDICAL SYSTEMS CORPORATION
K162187 08/04/2016 Xario 100 Diagnostic Ultrasound System, V5.0 Toshiba Medical Systems Corporation
K162183 08/04/2016 Vantage Galan 3T, MRT-3020, V4.0 TOSHIBA MEDICAL SYSTEMS CORPORATION
K132523 08/12/2013 MYOPERFUSION TOSHIBA MEDICAL SYSTEMS CORPORATION
K172646 09/01/2017 XIDF-AWS801, Angio Workstation, V7.0 Toshiba Medical Systems Corporation
K142465 09/02/2014 Aquilion ONE Vision, v7.0 TOSHIBA MEDICAL SYSTEMS CORPORATION
K132813 09/09/2013 DUAL ENERGY SYSTEM PACKAGE TOSHIBA MEDICAL SYSTEMS CORPORATION
K162614 09/19/2016 Infinix, INFX-8000V, V6.35 TOSHIBA MEDICAL SYSTEMS CORPORATION
K172863 09/20/2017 Infinix-i, INFX-8000V, V7.0 Toshiba Medical Systems Corporation
K152696 09/21/2015 INFX-8000V, V6.20 Toshiba Medical Systems Corporation
K142736 09/23/2014 XIDF-AWS801, Angio Workstation, v5.31 Toshiba Medical Systems Corporation
K152785 09/25/2015 XIDF-AWS801, Angio Workstation, V6.20 TOSHIBA MEDICAL SYSTEMS CORPORATION
K173088 09/29/2017 Vitrea Software Toshiba Package VSTP-001A Toshiba Medical Systems Corporation
K173090 09/29/2017 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 Toshiba Medical Systems Corporation
K063130 10/13/2006 APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0 TOSHIBA MEDICAL SYSTEMS CORPORATION
K072918 10/15/2007 MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00 TOSHIBA MEDICAL SYSTEMS CORPORATION
K113093 10/19/2011 VANTAGE TITAN 3T TOSHIBA MEDICAL SYSTEMS CORPORATION
K143008 10/20/2014 Vantage Titan 3T TOSHIBA MEDICAL SYSTEMS CORPORATION
K143027 10/21/2014 Xario 200, V3.0 TOSHIBA MEDICAL SYSTEMS CORPORATION
K143046 10/22/2014 Xario 100, V3.0 TOSHIBA MEDICAL SYSTEMS CORPORATION
K173382 10/30/2017 Vantage Galan 3T, V4.6 Toshiba Medical Systems Corporation
K173468 11/08/2017 Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 Toshiba Medical Systems Corporation
K143225 11/10/2014 INFX-8000V with Wireless Footswitch TOSHIBA MEDICAL SYSTEMS CORPORATION
K143223 11/10/2014 CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT TOSHIBA MEDICAL SYSTEMS CORPORATION
K153263 11/10/2015 Aquilion Lightning, TSX-035A/4 and /5, V7.0 TOSHIBA MEDICAL SYSTEMS CORPORATION
K123500 11/13/2012 AQUILION LB TRITON V4.91 TOSHIBA MEDICAL SYSTEMS CORPORATION
K133497 11/14/2013 AQUILION ONE VISION TOSHIBA MEDICAL SYSTEMS CORPORATION
K143281 11/14/2014 Ultimax-i TOSHIBA MEDICAL SYSTEMS CORPORATION
K143294 11/17/2014 Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways TOSHIBA MEDICAL SYSTEMS CORPORATION
K093891 12/18/2009 AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2 TOSHIBA MEDICAL SYSTEMS CORPORATION
K113715 12/19/2011 LUNG VOLUME ANALYSIS TOSHIBA MEDICAL SYSTEMS CORPORATION
K173962 12/28/2017 Viamo c100 TUS-VC100 Diagnostic Ultrasound System Toshiba Medical Systems Corporation
K163702 12/29/2016 Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 TOSHIBA MEDICAL SYSTEMS CORPORATION
K134025 12/30/2013 AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CT TOSHIBA MEDICAL SYSTEMS CORPORATION


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