FDA.reportPublic FDA data

HITACHI HIGH-TECH CORP., NAKA DIVISION

Matched from indexed company URL: Hitachi High-Tech Corp.

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

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
205681722095773K961481ELECSYS 2010 ANALYZERJJE1996-06-14
205681917102310K953239BOEHRINGER MANNHEIM/HITACHI 917 ANALYZERJJE1995-09-25
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
3492551731577215K181676Mini Ridge Filter and auxiliary functions for PROBEAT-VLHN2018-08-15
3492551256612214K171049Real Time Image Gating System for Proton Beam Therapy SystemsLHN2017-12-26
205681116639792K162606Elecsys TSH assay, cobas e 801 Immunoassay analyzerJLW2017-01-23
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
3492551116091047K153614PROBEAT-V and accessoriesLHN2016-04-21
3492551059800094K152867MHI-TM2000 Linear Accelerator System, VERO, ImavisIYE2015-10-21
3492551537454278K152592PROBEAT-VLHN2015-11-02
3492551423705266K152207Extended Range Shifter for PROBEAT-VLHN2015-10-02
3492551653434573K151132PROBEAT-VLHN2015-06-01
3492551414010768K122450MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVISIYE2012-10-03
205681740167288K100853COBAS 8000 MODULAR SERIES ANALYZERDCF2010-09-09
3492551446871865K073059PROBEAT WITH DISCRETE SPOT SCANNING SYSTEMLHN2007-12-10
3492551684268079K072047MHI-TM2000 LINEAR ACCELERATOR SYSTEMIYE2007-08-29
3492551140864266K060834PROBEAT WITH MGCSLHN2006-04-19
205681317530842K060373COBAS 6000 SERIES SYSTEMCEM2006-03-13
3492551533098742K053280PROBEATLHN2006-03-09
205681537339602BK110039
205681107527317
205681496452897
205681591483720
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
LHN142026-06-11
JJE101996-06-14
IYE32015-10-21
CFR12019-08-16
JLW12017-01-23
PDJ12016-12-19
DCF12010-09-09
CEM12006-03-13

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. 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