FDA 510(k) Applications Submitted by Hitachi Medical Systems America, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K083533 11/28/2008 ECHELON C MRI SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC.
K110120 01/18/2011 ECHELON RAPID CARDIAC COIL HITACHI MEDICAL SYSTEMS AMERICA, INC.
K150565 03/06/2015 Supria Whole-body X-ray CT System HITACHI MEDICAL SYSTEMS AMERICA, INC.
K050602 03/09/2005 ALTAIRE HITACHI MEDICAL SYSTEMS AMERICA, INC.
K110673 03/09/2011 HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL SYSTEMS AMERICA, INC.
K150595 03/09/2015 SCENARIA Phase 3 Whole-body X-ray CT System HITACHI MEDICAL SYSTEMS AMERICA, INC.
K091103 04/16/2009 GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS HITACHI MEDICAL SYSTEMS AMERICA, INC.
K151015 04/16/2015 ECHELON Oval V 5.0 MRI System HITACHI MEDICAL SYSTEMS AMERICA, INC.
K081198 04/28/2008 ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N HITACHI MEDICAL SYSTEMS AMERICA, INC.
K071506 06/01/2007 ECHELON SPECTROSCOPY PACKAGE HITACHI MEDICAL SYSTEMS AMERICA, INC.
K161748 06/24/2016 SUPRIA w/guideShot Option HITACHI MEDICAL SYSTEMS AMERICA, INC.
K101888 07/07/2010 SCENARIA WHOLE-BODY X-RAY CT SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC.
K162079 07/27/2016 TRILLIUM Oval Head Coil 32 HITACHI MEDICAL SYSTEMS AMERICA, INC.
K052172 08/09/2005 HHF1 MAGNETIC RESONANCE IMAGING SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC.
K032503 08/13/2003 EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL SYSTEMS AMERICA, INC.
K072279 08/16/2007 MAGNETIC RESONANCE DIAGNOSTIC DEVICE HITACHI MEDICAL SYSTEMS AMERICA, INC.
K142734 09/23/2014 TRILLIUM Oval MR System HITACHI MEDICAL SYSTEMS AMERICA, INC.
K093044 09/30/2009 OASIS MRI SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC.
K102901 09/30/2010 HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL SYSTEMS AMERICA, INC.
K033248 10/07/2003 HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC.
K083086 10/16/2008 ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150) HITACHI MEDICAL SYSTEMS AMERICA, INC.
K113145 10/25/2011 ECHELON OVAL MRI SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC.
K053148 11/10/2005 CXR16 HITACHI MEDICAL SYSTEMS AMERICA, INC.
K123509 11/13/2012 SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC.
K113341 11/14/2011 GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC.
K063518 11/21/2006 HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL SYSTEMS AMERICA, INC.
K053309 11/28/2005 ALTAIRE INTERVENTIONAL MR PACKAGE HITACHI MEDICAL SYSTEMS AMERICA, INC.
K153547 12/11/2015 ECHELON Oval V 5.1 MRI System Hitachi Medical Systems America, Inc.
K163528 12/16/2016 HITACHI Supria Whole-body X-ray CT System Phase 3 Hitachi Medical Systems America, Inc.
K080062 01/09/2008 OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120 HITACHI MEDICAL SYSTEMS AMERICA, INC.
K081745 06/19/2008 ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL HITACHI MEDICAL SYSTEMS AMERICA, INC.
K062556 08/30/2006 ECHELON SHOULDER COIL HITACHI MEDICAL SYSTEMS AMERICA, INC.
K143537 12/15/2014 Sirius Starmobile tiara HITACHI MEDICAL SYSTEMS AMERICA, INC.
K102889 09/30/2010 HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON HITACHI MEDICAL SYSTEMS AMERICA, INC.
K093466 11/06/2009 HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS HITACHI MEDICAL SYSTEMS AMERICA, INC.
K160152 01/22/2016 Trillium Oval V 5.1 MRI System HITACHI MEDICAL SYSTEMS AMERICA, INC.
K050307 02/08/2005 AIRIS ELITE RAPID BODY COIL HITACHI MEDICAL SYSTEMS AMERICA, INC.
K040902 04/07/2004 HITACHI PRESTO HITACHI MEDICAL SYSTEMS AMERICA, INC.
K001334 04/27/2000 HITACHI AIRIS II HITACHI MEDICAL SYSTEMS AMERICA, INC.
K021751 05/28/2002 ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC.
K071806 07/02/2007 ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC.
K061950 07/10/2006 HHF1 ECHELON MULTI-PURPOSE COIL HITACHI MEDICAL SYSTEMS AMERICA, INC.
K032232 07/21/2003 AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE HITACHI MEDICAL SYSTEMS AMERICA, INC.
K022390 07/23/2002 HITACHI ALTAIRE HITACHI MEDICAL SYSTEMS AMERICA, INC.
K002420 08/08/2000 HITACHI ALTAIRE HITACHI MEDICAL SYSTEMS AMERICA, INC.
K994378 12/27/1999 AIRIS II HITACHI MEDICAL SYSTEMS AMERICA, INC.
K063513 11/21/2006 ECHELON MR-RCC-150 CARDIAC COIL HITACHI MEDICAL SYSTEMS AMERICA, INC.
K042428 09/08/2004 SCEPTREP3 PET/CT HITACHI MEDICAL SYSTEMS AMERICA, INC.
K974498 11/28/1997 STRATIS II HITACHI MEDICAL SYSTEMS AMERICA, INC.
K960181 01/16/1996 VERSION 3.7 OPERATING SYSTEM SOFTWARE HITACHI MEDICAL SYSTEMS AMERICA, INC.
K971016 03/20/1997 MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52) HITACHI MEDICAL SYSTEMS AMERICA, INC.
K961174 03/25/1996 ECG MONITOR MODEL DS-3130/3140 HITACHI MEDICAL SYSTEMS AMERICA, INC.
K961876 05/15/1996 AIRIS HITACHI MEDICAL SYSTEMS AMERICA, INC.
K961969 05/20/1996 HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6 OPERATING SYSTEM SOFTWARE HITACHI MEDICAL SYSTEMS AMERICA, INC.
K962048 05/28/1996 1W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE) HITACHI MEDICAL SYSTEMS AMERICA, INC.
K974212 11/10/1997 AIRIS II HITACHI MEDICAL SYSTEMS AMERICA, INC.
K980691 02/23/1998 AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE HITACHI MEDICAL SYSTEMS AMERICA, INC.
K971279 04/07/1997 VERSION 4 OPERATING SYSTEM SOFTWARE HITACHI MEDICAL SYSTEMS AMERICA, INC.
K992650 08/06/1999 AIRIS, AIRIS II HITACHI MEDICAL SYSTEMS AMERICA, INC.
K984272 11/30/1998 MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000 HITACHI MEDICAL SYSTEMS AMERICA, INC.
K984274 11/30/1998 MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE HITACHI MEDICAL SYSTEMS AMERICA, INC.
K984278 11/30/1998 MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II HITACHI MEDICAL SYSTEMS AMERICA, INC.
K984280 11/30/1998 AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE HITACHI MEDICAL SYSTEMS AMERICA, INC.
K014240 12/26/2001 PRONTO HITACHI MEDICAL SYSTEMS AMERICA, INC.
K021314 04/25/2002 SCEPTRE-VS HITACHI MEDICAL SYSTEMS AMERICA, INC.
K011320 05/01/2001 ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC.
K991231 04/12/1999 HITACHI VERSIFLEX HITACHI MEDICAL SYSTEMS AMERICA, INC.
K964990 12/16/1996 HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30) HITACHI MEDICAL SYSTEMS AMERICA, INC.


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