Hitachi L T D Medical System Operations Group

FDA Filings

This page includes the latest FDA filings for Hitachi L T D Medical System Operations Group. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number8030405
FEI Number3008238760
NameHITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP
Owner & OperatorHITACHI, LTD.
Contact Address2-16-1, HIGASHI-UENO
TAITO-KU, TOKYO JP-NOTA 101-0015 JP
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2-1, SHINTOYOFUTA
KASHIWA-SHI, CHIBA-KEN Tokyo, 277-0804 JP
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
SSD-35002020-04-14
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
SSD-35002020-04-14
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
SSD-35002020-04-14
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Prosound 22020-04-07
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Prosound 22020-04-07
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Prosound 22020-04-07
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
PROUSOUND ALPHA 72020-03-25
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
PROUSOUND ALPHA 72020-03-25
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
PROUSOUND ALPHA 72020-03-25
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Prosound 62020-02-26
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Prosound 62020-02-26
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Prosound 62020-02-26
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
SCENARIA View2019-09-17
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
ARIETTA 7502019-08-26
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
ARIETTA 7502019-08-26
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
ARIETTA 7502019-08-26
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
ETG-41002019-07-01
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
ARIETTA 502019-04-16
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
ARIETTA 502019-04-16
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
ARIETTA 502019-04-16
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Arietta 652018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Arietta 652018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Arietta 652018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
ARIETTA 8502018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
ARIETTA 8502018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
ARIETTA 8502018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Arietta Precision2018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Arietta Precision2018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Arietta Precision2018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
ARIETTA Prologue2018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
ARIETTA Prologue2018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
ARIETTA Prologue2018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Lisendo 8802018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Lisendo 8802018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Lisendo 8802018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Noblus2018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Noblus2018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Noblus2018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Arietta60 / Arietta S60 / Arietta V602018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Arietta60 / Arietta S60 / Arietta V602018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Arietta60 / Arietta S60 / Arietta V602018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
ARIETTA 70 / ARIETTA S70 / ARIETTA V702018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
ARIETTA 70 / ARIETTA S70 / ARIETTA V702018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
ARIETTA 70 / ARIETTA S70 / ARIETTA V702018-12-18
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Hitachi Aloka Pipetting and Diluting Systems2017-12-06
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
MHI-TM2000 Linear Accelerator System, VERO, Imavis2017-04-26
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS2017-04-26
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
MHI-TM2000 LINEAR ACCELERATOR SYSTEM2017-04-26
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Supria2015-10-19
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Sirius Starmobile tiara2015-03-13
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
AIRIS II2015-03-12
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Trillium Oval2015-03-12
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon Oval2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon Oval RAPID Head/Neck/NV Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon Oval RAPID Breast Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon Oval RAPID Body Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon Oval2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon Oval RAPID Head/Neck/NV Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon Oval RAPID Breast Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon Oval RAPID Body Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon Oval2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon Oval RAPID Head/Neck/NV Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon Oval RAPID Breast Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon Oval RAPID Body Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon Small Extremity Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon NV Attachment Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Scenaria2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon Long Bone Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon Hi-Res Foot Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon PV Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon Knee/Extremity Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon Foot Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon RAPID Torso Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon RAPID Head Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Oasis RAPID NV Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Oasis RAPID Breast Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Oasis RAPID Foot Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Oasis Large Flexible Body Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Oasis Extra-large Flexible Body Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Oasis CTL Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Osis RAPID Knee Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Oasis2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Oasis RAPID Wrist Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Oasis RAPID Shoulder Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Oasis RAPID Head Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Oasis RAPID C-Spine Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Oasis RAPID Body Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Oasis Large Joint Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon Shoulder Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon Multi-purpose Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon QD Head Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon CTL Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon C-Spine Coil2013-01-31
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Hi Vision Ascendus2012-12-04
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Hi Vision Ascendus2012-12-04
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Hi Vision Ascendus2012-12-04
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Hi Vision Avius2011-06-29
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Hi Vision Avius2011-06-29
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Hi Vision Avius2011-06-29
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Hi Vision Preirus2011-06-29
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Hi Vision Preirus2011-06-29
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Hi Vision Preirus2011-06-29
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
EUB-55002011-06-29
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
EUB-55002011-06-29
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
EUB-55002011-06-29
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
ECLOS2007-11-12
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
CXR42007-11-12
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Hi Vision 9002007-11-12
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Hi Vision 9002007-11-12
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Hi Vision 9002007-11-12
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
ETG-40002007-11-12
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
ETG-1002007-11-12
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
Echelon RAPID Cardiac/Hip Coil2007-06-25
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
MRP-70002006-01-24
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
ALTAIRE2006-01-24
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
AIRIS2006-01-24
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
AIRIS II2006-01-24
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
AIRIS ELITE2006-01-24
HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP [HITACHI, LTD.]
CB MERCURAY2006-01-24

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