FDA 510(k) Applications Submitted by TOSHIBA AMERICA MEDICAL SYSTEMS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K131822 06/20/2013 ULTRAEXTEND USWS-900A V2.1 AND V3.1 TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K092179 07/21/2009 APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001 TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K072606 09/17/2007 AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K082830 09/26/2008 INFX-8000H, INFINIX-I TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K121076 04/09/2012 ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K122613 08/27/2012 VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K122842 09/17/2012 RADREX-I, SW V4.00 MODEL DRAD-3000E TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K002424 08/08/2000 3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K992992 09/07/1999 AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K993038 09/10/1999 TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.) TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K013608 10/31/2001 DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K982300 07/01/1998 TRANSVIEW (TRANSMISSION SYSTEM),MODEL NDTR-701A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K983516 10/07/1998 TRANSMISSION KIT, TRANS-CT, MODEL NSTR-050A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K983514 10/07/1998 POSITRON OPTION, MODEL NSCO-050A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K950972 03/02/1995 REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K961092 03/19/1996 VISART TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K941593 04/01/1994 DIAGNOSTIC ULTRASONIC TRANSDUCER TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K965068 12/18/1996 MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K051763 06/30/2005 QD KNEE/FOOT COIL, MODEL MJQJ-147A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K022400 07/23/2002 SSA-700A, APLIO DIAGNOSTIC ULTRASOUND SYSTEM TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K032490 08/12/2003 TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2 TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K023207 09/25/2002 OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT) TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K052884 10/13/2005 MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K023511 10/21/2002 EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2 TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K051833 07/06/2005 TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K080038 01/07/2008 VANTAGE TITAN, MODEL MRT-1504/S3 TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K110066 01/10/2011 AQUILION PRIME TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K100067 01/11/2010 MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K990134 01/14/1999 MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI) TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K010129 01/16/2001 EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K090158 01/22/2009 APLIO ARTIDA V2.0 SSH-880CV TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K080160 01/23/2008 APLIO ARTIDA, MODEL SSH-880CV DIAGNOSTIC ULTRASOUND SYSTEM TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K080211 01/29/2008 MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K020385 02/05/2002 CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TSX-101A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K050380 02/15/2005 XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K990490 02/16/1999 SSA-320A JUST VISION 200/ SSA-325A JUST VISION TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K050458 02/23/2005 TSX-201A AQUILION LB CT SCANNER TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K010631 03/02/2001 NEMIO TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K140729 03/24/2014 APLIO ARTIDA, V3.2 TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K110870 03/29/2011 APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K081065 04/15/2008 APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2 TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K981397 04/17/1998 HARMONIC IMAGING AND FLASH ECHO IMAGING FUNCTION FOR THE DIAGNOSTIC ULTRASOUND SYSTEM SSA-380A, POWERVISION 7000 TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K061187 04/28/2006 TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K091295 05/04/2009 APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0 TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K031469 05/09/2003 AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7 TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K991710 05/19/1999 SSA-370A/POWERVISION 6000 TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K991766 05/24/1999 ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K081482 05/28/2008 CSBP-001A BODY ORGAN PERFUSION SYSTEM TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K991858 06/01/1999 SSA-390A/POWER VISION 8000 TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K081582 06/05/2008 INFX-8000V, INFINIX-CFI AND INFINIX VFI TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K051500 06/07/2005 FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K061605 06/09/2006 NEMIO XG, SAA-580A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K081621 06/09/2008 INFX-8000C (INFINIX CC-I AND VC-I) TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K081624 06/10/2008 INFX-8000F (INFINIX CSI AND INFINIX DPI) TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K111633 06/13/2011 AQUILION LB MOVEMENT BASE KIT TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K022050 06/24/2002 CGS-31A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER. TSX-101A (AQUILION ADVANCE MULTI) TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K982265 06/29/1998 AQUILION CT SCANNER, MODEL TSX-101A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K101868 07/02/2010 INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K132106 07/08/2013 INFINIX ANGIO WORKSTATION W/DTS SOFTWARE TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K061976 07/13/2006 CKIS-004A INJECTOR SYNCHRONIZATION OPTION TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K122109 07/17/2012 AQUILION ONE VISION, V4.90 TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K072000 07/23/2007 APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.0 TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K032281 07/24/2003 SSA-770A - VERSION 4, APLIO DIAGNOSTIC ULTRASOUND SYSTEM TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K082119 07/28/2008 APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0 TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K082244 08/08/2008 PCA-8000A, MARK 11, PET / CT SYSTEM TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K982787 08/10/1998 ASTEION CT SCANNER, TSX-021A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K982976 08/26/1998 ULTRASOUND WORKSTATION, UIWS-300A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K992886 08/26/1999 POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K082494 08/29/2008 DRAD3000E/RADREX-I TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K082596 09/08/2008 ULTRAEXTEND USWS-900A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K082684 09/15/2008 4D VIEWER RADIOLOGY, MODEL USWP-100A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K072693 09/24/2007 CSNP-001A NEURO PACKAGE TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K092948 09/24/2009 APLIO MX SSA-780A, VERSION 1.0 TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K013214 09/26/2001 CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K072737 09/27/2007 CSCS-001A CALCIUM SCORING PACKAGE TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K123097 10/02/2012 DOSE TRACKING SYSTEM MODEL XIDF-DTS801 TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K072826 10/03/2007 APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K112989 10/06/2011 AQUILION CXL TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K093171 10/08/2009 VIAMO SSA-640A VERSION 1.2 TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K083014 10/09/2008 ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K113052 10/13/2011 INFINIX-CCI TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K973908 10/14/1997 AUKLET CT SCANNER, TSX-003A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K063184 10/20/2006 MODEL CVV-001A VESSEL VIEW SOFTWARE OPTION TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K063189 10/20/2006 TSX-301A, AQUILION ONE CT SYSTEM TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K063241 10/26/2006 CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K033418 10/27/2003 TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K053043 10/28/2005 ENCOMPASS SOFTWARE PACKAGE TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K073081 11/01/2007 JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K013633 11/05/2001 SSA-770A, APLIO ULTRASOUND SYSTEM TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K063361 11/07/2006 EXCELART VANTAGE ATLAS, MODEL MRT-1503 TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K083282 11/07/2008 MODEL TSX-301B AQUILION CT SYSTEM TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K023760 11/08/2002 CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K043078 11/08/2004 NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K073165 11/09/2007 DRAD-3000E, RADREX-I TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K043111 11/10/2004 PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K133553 11/19/2013 KALARE TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K073259 11/20/2007 XIDF-100A/B1 IMAGE PROCESSOR TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K083503 11/26/2008 DRAD30003/RADREX-I TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K103629 12/13/2010 PET-512MC TRANSESOPHAGEAL TRANSDUCER TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K970047 01/06/1997 PHASED ARRAY TRANSDUCER - - PSK-20CT TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K960602 01/16/1996 SSA-340A (MODIFICATION) TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K972771 07/24/1997 PHASED ARRAY TRANSDUCER - - PVF -375DT TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K963705 09/16/1996 COLOR ENHANCEMENT FUNCTION FOR THE SSA-380A TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K964865 12/04/1996 PVK-720ST ENDOCAVITARY TRANSDUCER TOSHIBA AMERICA MEDICAL SYSTEMS, INC.


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