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
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
3439321207652943K053280PROBEATLHN2006-03-09
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
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
LHN152024-01-12
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#

PROBEAT-FR

2024-01-12

Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

ARIETTA 65

2018-07-18

Hitachi Healthcare Americas Corporation

PROBEAT-V

2015-11-02

Hitachi, Ltd.,Health Care Company

200 records. Showing 1-40. Next

GUDID#

PROBEAT - The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Small Field Applicator is an optional accessory to the proton beam therapy system which can be added to the nozzle configuration of the cleared PROBEAT-V system to make the lateral penumbra sharp, as needed. The Small Field Applicator may be used in place of the optional removable Applicator having an aperture (collimator) that has been cleared as part of the PROBEAT-V system.

HITACHI HIGH-TECH CORPORATION

2026-04-01

PROBEAT - The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. The Mini Ridge Filter is an optional accessory to modify the beam of the PROBEAT-V system. As auxiliary functions, a beam gating function and a fluoroscopy function during proton beam irradiation are added.

HITACHI HIGH-TECH CORPORATION

2026-04-01

PROBEAT - The PROBEAT with MGCS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The only difference between the PROBEAT with MGCS and the cleared PROBEAT is the addition of the MGCS that converts the scale and format of the dimensional data of the patient specific aperture and/or compensator generated by commercially available patient treatment planning/management software into the scale and format used by an industrial, computer controlled milling machine to enable the milling machine to fashion the required aperture or compensator for patient treabment.

HITACHI HIGH-TECH CORPORATION

2026-04-01

PROBEAT - The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Small Field Applicator is an optional accessory to the proton beam therapy system which can be added to the nozzle configuration of the cleared PROBEAT-V system to make the lateral penumbra sharp, as needed. The Small Field Applicator may be used in place of the optional removable Applicator having an aperture (collimator) that has been cleared as part of the PROBEAT-V system.

HITACHI HIGH-TECH CORPORATION

2026-04-01

PROBEAT - The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Small Field Applicator is an optional accessory to the proton beam therapy system which can be added to the nozzle configuration of the cleared PROBEAT-V system to make the lateral penumbra sharp, as needed. The Small Field Applicator may be used in place of the optional removable Applicator having an aperture (collimator) that has been cleared as part of the PROBEAT-V system.

HITACHI, LTD.

2026-01-20

PROBEAT - The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Small Field Applicator is an optional accessory to the proton beam therapy system which can be added to the nozzle configuration of the cleared PROBEAT-V system to make the lateral penumbra sharp, as needed. The Small Field Applicator may be used in place of the optional removable Applicator having an aperture (collimator) that has been cleared as part of the PROBEAT-V system.

HITACHI, LTD.

2023-10-02

200 records. Showing 1-40. Next