FDA 510(k) Applications Submitted by Doug Thistlethwaite

FDA 510(k) Number Submission Date Device Name Applicant
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.
K180901 04/06/2018 Low Dose CT Lung Cancer Screening Option Hitachi Healthcare Americas
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.
K181376 05/24/2018 ARIETTA 65 Hitachi Healthcare Americas Corporation
K071506 06/01/2007 ECHELON SPECTROSCOPY PACKAGE HITACHI MEDICAL SYSTEMS AMERICA, INC.
K171708 06/08/2017 ALOKA ARIETTA 850 Hitachi Healthcare Americas Corporation
K061608 06/09/2006 MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL CORP.
K171738 06/12/2017 Supria True64 Hitachi Healthcare Americas Corporation
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.
K172110 07/13/2017 ECHELON OVAL V6.0A MRI System Hitachi Healthcare Americas Corporation
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.
K172492 08/17/2017 Optical Topography System ETG-4100 Hitachi Healthcare Americas
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.
K053258 11/22/2005 EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL CORP.
K183291 11/26/2018 Supria True64 Whole-Body X-Ray CT System Hitachi Healthcare Americas
K053309 11/28/2005 ALTAIRE INTERVENTIONAL MR PACKAGE HITACHI MEDICAL SYSTEMS AMERICA, INC.
K173739 12/07/2017 ALOKA ARIETTA 850 Hitachi Healthcare Americas Corporation
K153547 12/11/2015 ECHELON Oval V 5.1 MRI System Hitachi Medical Systems America, Inc.
K183456 12/13/2018 Aloka Arietta 850 Hitachi Healthcare Americas
K163528 12/16/2016 HITACHI Supria Whole-body X-ray CT System Phase 3 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.
K042428 09/08/2004 SCEPTREP3 PET/CT HITACHI MEDICAL SYSTEMS AMERICA, INC.


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