Hitachi Medical Systems America Inc

FDA Filings

This page includes the latest FDA filings for Hitachi Medical Systems America Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
Hitachi Medical Systems America, Inc.
HITACHI Supria Whole-body X-ray CT System Phase 32017-03-03
HITACHI MEDICAL SYSTEMS AMERICA, INC.
TRILLIUM Oval Head Coil 322016-09-16
HITACHI MEDICAL SYSTEMS AMERICA, INC.
SUPRIA W/guideShot Option2016-08-17
HITACHI MEDICAL SYSTEMS AMERICA, INC.
Trillium Oval V 5.1 MRI System2016-05-20
Hitachi Medical Systems America, Inc.
ECHELON Oval V 5.1 MRI System2016-03-31
HITACHI MEDICAL SYSTEMS AMERICA, INC.
SCENARIA Phase 3 Whole-body X-ray CT System2015-10-30
HITACHI MEDICAL SYSTEMS AMERICA, INC.
Supria Whole-body X-ray CT System2015-09-30
HITACHI MEDICAL SYSTEMS AMERICA, INC.
ECHELON Oval V 5.0 MRI System2015-07-29
HITACHI MEDICAL SYSTEMS AMERICA, INC.
Sirius Starmobile Tiara2015-03-06
HITACHI MEDICAL SYSTEMS AMERICA, INC.
TRILLIUM Oval MR System2015-03-02
HITACHI MEDICAL SYSTEMS AMERICA, INC.
SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM2013-03-29
HITACHI MEDICAL SYSTEMS AMERICA, INC.
GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM2012-05-03
HITACHI MEDICAL SYSTEMS AMERICA, INC.
ECHELON OVAL MRI SYSTEM2012-05-01
HITACHI MEDICAL SYSTEMS AMERICA, INC.
HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER2011-09-27
HITACHI MEDICAL SYSTEMS AMERICA, INC.
SCENARIA WHOLE-BODY X-RAY CT SYSTEM2011-04-08
HITACHI MEDICAL SYSTEMS AMERICA, INC.
ECHELON RAPID CARDIAC COIL2011-02-25
HITACHI MEDICAL SYSTEMS AMERICA, INC.
HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON2010-12-20
HITACHI MEDICAL SYSTEMS AMERICA, INC.
HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER2010-10-27
HITACHI MEDICAL SYSTEMS AMERICA, INC.
HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS2010-06-17
HITACHI MEDICAL SYSTEMS AMERICA, INC.
OASIS MRI SYSTEM2010-03-16
HITACHI MEDICAL SYSTEMS AMERICA, INC.
GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS2009-06-15
HITACHI MEDICAL SYSTEMS AMERICA, INC.
ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)2008-12-05
HITACHI MEDICAL SYSTEMS AMERICA, INC.
ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL2008-08-12
HITACHI MEDICAL SYSTEMS AMERICA, INC.
ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N2008-06-18
HITACHI MEDICAL SYSTEMS AMERICA, INC.
OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-1202008-02-11
HITACHI MEDICAL SYSTEMS AMERICA, INC.
MAGNETIC RESONANCE DIAGNOSTIC DEVICE2007-09-21
HITACHI MEDICAL SYSTEMS AMERICA, INC.
ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM2007-08-28
HITACHI MEDICAL SYSTEMS AMERICA, INC.
ECHELON SPECTROSCOPY PACKAGE2007-06-28
HITACHI MEDICAL SYSTEMS AMERICA, INC.
HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER2006-12-21
HITACHI MEDICAL SYSTEMS AMERICA, INC.
ECHELON MR-RCC-150 CARDIAC COIL2006-12-12
HITACHI MEDICAL SYSTEMS AMERICA, INC.
ECHELON SHOULDER COIL2006-10-05
HITACHI MEDICAL SYSTEMS AMERICA, INC.
HHF1 ECHELON MULTI-PURPOSE COIL2006-08-18
HITACHI MEDICAL SYSTEMS AMERICA, INC.
CXR162006-02-17
HITACHI MEDICAL SYSTEMS AMERICA, INC.
ALTAIRE INTERVENTIONAL MR PACKAGE2006-01-24
HITACHI MEDICAL SYSTEMS AMERICA, INC.
HHF1 MAGNETIC RESONANCE IMAGING SYSTEM2005-09-27
HITACHI MEDICAL SYSTEMS AMERICA, INC.
ALTAIRE2005-04-07
HITACHI MEDICAL SYSTEMS AMERICA, INC.
AIRIS ELITE RAPID BODY COIL2005-02-28
HITACHI MEDICAL SYSTEMS AMERICA, INC.
SCEPTREP3 PET/CT2004-09-17
HITACHI MEDICAL SYSTEMS AMERICA, INC.
HITACHI PRESTO2004-04-21
HITACHI MEDICAL SYSTEMS AMERICA, INC.
HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM2003-10-20
HITACHI MEDICAL SYSTEMS AMERICA, INC.
AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE2003-09-29
HITACHI MEDICAL SYSTEMS AMERICA, INC.
EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER2003-08-22
HITACHI MEDICAL SYSTEMS AMERICA, INC.
ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM2002-08-15
HITACHI MEDICAL SYSTEMS AMERICA, INC.
SCEPTRE-VS2002-07-02
HITACHI MEDICAL SYSTEMS AMERICA, INC.
ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM2001-08-09
HITACHI MEDICAL SYSTEMS AMERICA, INC.
HITACHI ALTAIRE2000-10-17
HITACHI MEDICAL SYSTEMS AMERICA, INC.
HITACHI AIRIS II2000-07-06
HITACHI MEDICAL SYSTEMS AMERICA, INC.
AIRIS II2000-03-07
HITACHI MEDICAL SYSTEMS AMERICA, INC.
AIRIS, AIRIS II1999-10-08
HITACHI MEDICAL SYSTEMS AMERICA, INC.
HITACHI VERSIFLEX1999-05-24
HITACHI MEDICAL SYSTEMS AMERICA, INC.
AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE1999-02-08
HITACHI MEDICAL SYSTEMS AMERICA, INC.
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE1999-01-25
HITACHI MEDICAL SYSTEMS AMERICA, INC.
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II1998-12-11
HITACHI MEDICAL SYSTEMS AMERICA, INC.
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-50001998-12-11
HITACHI MEDICAL SYSTEMS AMERICA, INC.
AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE1998-05-11
HITACHI MEDICAL SYSTEMS AMERICA, INC.
STRATIS II1998-02-26
HITACHI MEDICAL SYSTEMS AMERICA, INC.
AIRIS II1998-02-09
HITACHI MEDICAL SYSTEMS AMERICA, INC.
VERSION 4 OPERATING SYSTEM SOFTWARE1997-07-03
HITACHI MEDICAL SYSTEMS AMERICA, INC.
MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52)1997-06-06
HITACHI MEDICAL SYSTEMS AMERICA, INC.
HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)1997-02-26
HITACHI MEDICAL SYSTEMS AMERICA, INC.
HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6 OPERATING SYSTEM SOFTWARE1996-09-05
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE)1996-08-14
HITACHI MEDICAL SYSTEMS AMERICA, INC.
AIRIS1996-07-25
HITACHI MEDICAL SYSTEMS AMERICA, INC.
ECG MONITOR MODEL DS-3130/31401996-06-21
HITACHI MEDICAL SYSTEMS AMERICA, INC.
VERSION 3.7 OPERATING SYSTEM SOFTWARE1996-03-05
HITACHI MEDICAL SYSTEMS AMERICA, INC.
IRIS BILATERAL TMJ1995-10-23
HITACHI MEDICAL SYSTEMS AMERICA, INC.
QD BILATERAL BREAST COIL1995-10-17
HITACHI MEDICAL SYSTEMS AMERICA, INC.
MAGNETIC RESONANCE DIAGNOSTIC DEVICE1995-09-12
HITACHI MEDICAL SYSTEMS AMERICA, INC.
AIRIS1995-05-24
HITACHI MEDICAL SYSTEMS AMERICA, INC.
MRH-15001995-05-12
HITACHI MEDICAL SYSTEMS AMERICA, INC.
STRATIS1995-03-21
HITACHI MEDICAL SYSTEMS AMERICA, INC.
2D,3D, TOF MR ANGIOGRAPHY1994-12-30
HITACHI MEDICAL SYSTEMS AMERICA, INC.
VERSION 5 OPERATING SYSTEM SOFTWARE1994-12-09
HITACHI MEDICAL SYSTEMS AMERICA, INC.
QUAD PELVIS COIL1994-09-23
HITACHI MEDICAL SYSTEMS AMERICA, INC.
MAGNETIC RESONANCE DIAGNOSTIC DEVICE1994-09-09
HITACHI MEDICAL SYSTEMS AMERICA, INC.
EXTRA LARGE QUAD FLEX SPINE COIL1994-05-23
HITACHI MEDICAL SYSTEMS AMERICA, INC.
DIAGNOSTIC ULTRASOUND SYSTEM1994-05-03
HITACHI MEDICAL SYSTEMS AMERICA, INC.
2D, 3D TOF MR ANGIOGRAPHY1994-03-30
HITACHI MEDICAL SYSTEMS AMERICA, INC.
VERSION 3 OPERATING SYSTEM SOFTWARE1994-03-30
HITACHI MEDICAL SYSTEMS AMERICA, INC.
FAST SPIN ECHO1994-03-16
HITACHI MEDICAL SYSTEMS AMERICA, INC.
HITACHI MPR-5000 & MPR-7000 MAGNETIC RESONANCE DIAGNOSTIC DEVICE MODIFICATION1994-01-25
HITACHI MEDICAL SYSTEMS AMERICA, INC.
EXTRA LARGE QUAD FLEX SPINE COIL1994-01-05
HITACHI MEDICAL SYSTEMS AMERICA, INC.
FAST SPIN ECHO1993-12-27
HITACHI MEDICAL SYSTEMS AMERICA, INC.
ECG GATING HARDWARE FOR MRP-5000 AND MRP-70001993-11-12
HITACHI MEDICAL SYSTEMS AMERICA, INC.
MRH-15001993-06-08
HITACHI MEDICAL SYSTEMS AMERICA, INC.
FAST SPIN ECHO MEASURING FUNCTION1993-03-18
HITACHI MEDICAL SYSTEMS AMERICA, INC.
2D TOF ANGIOGRAHY MEASURING FUNCTION1993-02-12
HITACHI MEDICAL SYSTEMS AMERICA, INC.
MRP-5000 AND 7000 BILATERAL/UNILATERAL TMJ COIL1992-12-24
HITACHI MEDICAL SYSTEMS AMERICA, INC.
EUB-4051992-12-10
HITACHI MEDICAL SYSTEMS AMERICA, INC.
MAGNETIC RESONANCE DIAGNOSTIC DEVICE1992-08-25
HITACHI MEDICAL SYSTEMS AMERICA, INC.
3D TOF ANGIOGRAPHY MEASURING FUNCTION1992-07-30
HITACHI MEDICAL SYSTEMS AMERICA, INC.
MOBILE MRP-70001992-03-05
HITACHI MEDICAL SYSTEMS AMERICA, INC.
MRP-5000 & MRP-7000 HS/MR QUADRATURE KNEE COILS1991-11-22
HITACHI MEDICAL SYSTEMS AMERICA, INC.
MRH-5001991-11-22
HITACHI MEDICAL SYSTEMS AMERICA, INC.
MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31)1991-11-01
HITACHI MEDICAL SYSTEMS AMERICA, INC.
HITACHI MRP-7000 MAGNETIC ROSONANCE DEVICE1991-05-30
HITACHI MEDICAL SYSTEMS AMERICA, INC.
MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION1991-05-30

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2019061064539Algeciras,Spain -> New York/Newark Area, Newark, New JerseyMOCK UP OASIS, MOCK UP GENTRY5 PKG
2018101567450Tokyo ,Japan -> Los Angeles, CaliforniaEXHIBITION GOODS FOR RSNA MRI SYSTEM MOCK-UP HS#90230013 PKG
2018101567450Tokyo ,Japan -> Los Angeles, CaliforniaEXHIBITION GOODS FOR RSNA MRI SYSTEM MOCK-UP HS#90230013 PKG
2018101567450Tokyo ,Japan -> Los Angeles, CaliforniaEXHIBITION GOODS FOR RSNA MRI SYSTEM MOCK-UP HS#90230013 PKG
2018100349067Tokyo ,Japan -> Long Beach, CaliforniaEXHIBITION GOODS HS#8471491 CAS
2018092846291Tokyo ,Japan -> Long Beach, CaliforniaEXHIBITION GOODS HS#8471491 CAS
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