FDA.reportPublic FDA data

HITACHI HIGH-TECH CORP., NAKA DIVISION

Matched from indexed company URL: Hitachi , Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96146733003559576HITACHI HIGH-TECH CORP., NAKA DIVISION1N2026-01-01882 ICHIGE Hitachinaka-shi Ibaraki JP 312-8504
10001622061000162206HITACHI HIGH-TECH CORP., KASHIWANOHA1N2026-01-01226-44-141-1, WAKASHIBA KASHIWA-SHI Chiba JP 277-0871
30039938953003993895HITACHI HIGH-TECH AMERICA, INC. RADIATION THERAPY DIVISION1Y2026-01-012535 Augustine Dr Santa Clara CA US 95054
30315703693031570369HITACHI HIGH-TECH CORP., Musashimurayama Center1N2026-01-011-26-37 Inadaira Musashimurayama Tokyo JP 208-0023
15280281528028HITACHI HEALTHCARE AMERICAS CORPORATION1Y2020-04-251959 SUMMIT COMMERCE PARK TWINSBURG OH US 44087
80304053008238760HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP1N2020-04-252-1, SHINTOYOFUTA KASHIWA-SHI, CHIBA-KEN Tokyo JP 277-0804
30039938953003993895HITACHI AMERICA, LTD., PARTICLE THERAPY DIVISION1Y2020-04-2550 Prospect Avenue Tarrytown NY US 10591
30116172523011617252Hitachi Healthcare Americas Corp. Informatics Division1N2020-04-25204 Westfield Street Greenville SC US 29601

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
105911107348985K974212AIRIS IILNH1998-02-09
205681722095773K961481ELECSYS 2010 ANALYZERJJE1996-06-14
205681917102310K953239BOEHRINGER MANNHEIM/HITACHI 917 ANALYZERJJE1995-09-25
105911655696750K945155AIRISLNH1995-05-24
205681181422550K942364HITACHI 914 ANALYZERJJE1994-10-04
205681906504812K921661BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZERJJE1992-06-30
205681153092847K901003BOEHRINGER MANNHEIM/HITACHI 747 CHEMISTRY ANALYZERJJE1990-04-16
205681203302215K872494HITACHI 717 CHEMISTRY ANALYZERJJE1987-07-09
205681100151788K860748HITACHI 736JJE1986-04-17
205681764616344K854025HITACHI 704JJE1985-10-28
205682013236983K843283BOEHRINGER MANNHEIM DIAGNOSTICS ADAMJJE1984-10-05
205681936275524K811194HITACHI 705 AUTOMATIC BLOOD CHEMISTRYJJE1981-05-27
3492551583269899K260174PROBEAT-CRLHN2026-06-11
3492551296025619K232032PROBEAT-FRLHN2024-01-12
3492551815372441K220883Small Field ApplicatorLHN2022-12-15
205681794665845K191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsCFR2019-08-16
3492551981933960K191801PROBEAT-CRLHN2019-09-13
105912056953809K191233ARIETTA 750IYN2019-08-09
105911135760785K190841SCENARIA ViewJAK2019-09-13
105911914772838K190248ARIETTA 50IYN2019-04-02
3492551731577215K181676Mini Ridge Filter and auxiliary functions for PROBEAT-VLHN2018-08-15
105911337406557K181376ARIETTA 65IYN2018-07-18
105911173939679K172492Optical Topography System ETG-4100DQA2018-08-17
105911301495521K171708ALOKA ARIETTA 850IYN2017-10-31
3492551256612214K171049Real Time Image Gating System for Proton Beam Therapy SystemsLHN2017-12-26
105911189440767K163505ARIETTA PRECISIONIYN2017-05-30
105911133385024K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersIYN2016-12-15
205681116639792K162606Elecsys TSH assay, cobas e 801 Immunoassay analyzerJLW2017-01-23
105911496926810K162583ALOKA LISENDO 880IYN2016-11-17
3492551805071067K161163PROBEAT-V Proton Beam Therapy System with X-ray Limiting AccessoryLHN2016-07-13
205682005652753K160571cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 AssayPDJ2016-12-19
105912049043625K160559NOBLUS™ Ultrasound Diagnostic SystemIYN2016-10-18
3492551116091047K153614PROBEAT-V and accessoriesLHN2016-04-21
3492551059800094K152867MHI-TM2000 Linear Accelerator System, VERO, ImavisIYE2015-10-21
105911353380610K152867MHI-TM2000 Linear Accelerator System, VERO, ImavisIYE2015-10-21
3492551537454278K152592PROBEAT-VLHN2015-11-02
3492551423705266K152207Extended Range Shifter for PROBEAT-VLHN2015-10-02
3492551653434573K151132PROBEAT-VLHN2015-06-01
105911141503504K150565Supria Whole-body X-ray CT SystemJAK2015-09-30
105911144643327K143537Sirius Starmobile tiaraIZL2015-03-06
105911040063857K142734TRILLIUM Oval MR SystemLNH2015-03-02
105911217495034K140443ARIETTA 60/ARIETTAS60/ARIETTAV60IYN2014-06-16
105911333393107K134016ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNERIYN2014-03-28
105911354799160K122537PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0IYN2013-04-12
3492551414010768K122450MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVISIYE2012-10-03
105911788315941K122450MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVISIYE2012-10-03
105911965379353K113145ECHELON OVAL MRI SYSTEMLNH2012-05-01
105911942622901K111227ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEMIYN2011-05-13
105911946561617K110673HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNERIYN2011-09-27
105911473434713K102901HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNERIYN2010-10-27
105912037383489K102889HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELONMOS2010-12-20
105911228897498K101888SCENARIA WHOLE-BODY X-RAY CT SYSTEMJAK2011-04-08
205681740167288K100853COBAS 8000 MODULAR SERIES ANALYZERDCF2010-09-09
105912022089143K093466HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUSIYO2010-06-17
105911001631810K092330OC-SENSOR DIANA IFOB TESTOOX2010-01-08
2156621050656512K083910VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWERLLZ2009-04-15
105911124654568K083254ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEMIYN2008-12-19
105911234580841K083086ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)MOS2008-12-05
105911425228100K081745ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COILMOS2008-08-12
105911724646574K081198ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150NMOS2008-06-18
105911895744702K080945FCR GO PORTABLE DIGITAL X-RAY SYSTEMIZL2008-04-18
105911397235165K080176ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEMIYN2008-02-29
105911520006605K080062OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120MOS2008-02-11
105911173380760K073310OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COILMOS2008-01-18
3492551446871865K073059PROBEAT WITH DISCRETE SPOT SCANNING SYSTEMLHN2007-12-10
105911627728904K072279MAGNETIC RESONANCE DIAGNOSTIC DEVICELNH2007-09-21
105911230552315K072047MHI-TM2000 LINEAR ACCELERATOR SYSTEMIYE2007-08-29
3492551684268079K072047MHI-TM2000 LINEAR ACCELERATOR SYSTEMIYE2007-08-29
105911027903761K071806ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEMJAK2007-08-28
105911350134878K063518HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNERIYN2006-12-21
105911016889672K063513ECHELON MR-RCC-150 CARDIAC COILMOS2006-12-12
105911351107577K062556ECHELON SHOULDER COILMOS2006-10-05
105911694669255K061950HHF1 ECHELON MULTI-PURPOSE COILMOS2006-08-18
105911622485988K061608MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNERIYN2006-11-22
3492551140864266K060834PROBEAT WITH MGCSLHN2006-04-19
205681317530842K060373COBAS 6000 SERIES SYSTEMCEM2006-03-13
637261117743487K053280PROBEATLHN2006-03-09
3492551533098742K053280PROBEATLHN2006-03-09
105911144971626K052172HHF1 MAGNETIC RESONANCE IMAGING SYSTEMLNH2005-09-27
105911031941604K051218MODIFICATION TO: UNICAP SPECIFIC IGEDHB2005-06-09
105911355704303K042501ETG-4000 OPTICAL TOPOGRAPHY SYSTEMDQA2004-10-12
105911858781389K033248HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEMMUH2003-10-20
205681537339602BK110039
321001081985967
205681107527317
205681496452897
205681591483720
105911781681851
205681095040831
3295831107527317
205681116639792
3439321207652943
205681210896342
205681317530842
205681537339602
205681551555163
3295831556227634
205681709069782
205681722095773
205681740167288
205681794665845
205682005652753

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN182019-08-09
LHN152026-06-11
JJE101996-06-14
MOS92010-12-20
IYE62015-10-21
LNH62015-03-02
JAK42019-09-13
DQA22018-08-17
IZL22015-03-06
CFR12019-08-16
JLW12017-01-23
PDJ12016-12-19
DCF12010-09-09
IYO12010-06-17
OOX12010-01-08
LLZ12009-04-15
CEM12006-03-13
DHB12005-06-09
MUH12003-10-20

PMN#

200 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next