HITACHI HIGH-TECH CORP., NAKA DIVISION

Matched from indexed company URL: HITACHI HIGH-TECH CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
9614673	3003559576	HITACHI HIGH-TECH CORP., NAKA DIVISION	1	N	2026-01-01	882 ICHIGE Hitachinaka-shi Ibaraki JP 312-8504
1000162206	1000162206	HITACHI HIGH-TECH CORP., KASHIWANOHA	1	N	2026-01-01	226-44-141-1, WAKASHIBA KASHIWA-SHI Chiba JP 277-0871
3003993895	3003993895	HITACHI HIGH-TECH AMERICA, INC. RADIATION THERAPY DIVISION	1	Y	2026-01-01	2535 Augustine Dr Santa Clara CA US 95054
3031570369	3031570369	HITACHI HIGH-TECH CORP., Musashimurayama Center	1	N	2026-01-01	1-26-37 Inadaira Musashimurayama Tokyo JP 208-0023

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
20568	1722095773	K961481	ELECSYS 2010 ANALYZER	JJE	1996-06-14
20568	1917102310	K953239	BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER	JJE	1995-09-25
20568	1181422550	K942364	HITACHI 914 ANALYZER	JJE	1994-10-04
20568	1906504812	K921661	BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER	JJE	1992-06-30
20568	1153092847	K901003	BOEHRINGER MANNHEIM/HITACHI 747 CHEMISTRY ANALYZER	JJE	1990-04-16
20568	1203302215	K872494	HITACHI 717 CHEMISTRY ANALYZER	JJE	1987-07-09
20568	1100151788	K860748	HITACHI 736	JJE	1986-04-17
20568	1764616344	K854025	HITACHI 704	JJE	1985-10-28
20568	2013236983	K843283	BOEHRINGER MANNHEIM DIAGNOSTICS ADAM	JJE	1984-10-05
20568	1936275524	K811194	HITACHI 705 AUTOMATIC BLOOD CHEMISTRY	JJE	1981-05-27
349255	1583269899	K260174	PROBEAT-CR	LHN	2026-06-11
349255	1296025619	K232032	PROBEAT-FR	LHN	2024-01-12
349255	1815372441	K220883	Small Field Applicator	LHN	2022-12-15
20568	1794665845	K191899	Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions	CFR	2019-08-16
349255	1981933960	K191801	PROBEAT-CR	LHN	2019-09-13
349255	1731577215	K181676	Mini Ridge Filter and auxiliary functions for PROBEAT-V	LHN	2018-08-15
349255	1256612214	K171049	Real Time Image Gating System for Proton Beam Therapy Systems	LHN	2017-12-26
20568	1116639792	K162606	Elecsys TSH assay, cobas e 801 Immunoassay analyzer	JLW	2017-01-23
349255	1805071067	K161163	PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory	LHN	2016-07-13
20568	2005652753	K160571	cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay	PDJ	2016-12-19
349255	1116091047	K153614	PROBEAT-V and accessories	LHN	2016-04-21
349255	1059800094	K152867	MHI-TM2000 Linear Accelerator System, VERO, Imavis	IYE	2015-10-21
349255	1537454278	K152592	PROBEAT-V	LHN	2015-11-02
349255	1423705266	K152207	Extended Range Shifter for PROBEAT-V	LHN	2015-10-02
349255	1653434573	K151132	PROBEAT-V	LHN	2015-06-01
349255	1414010768	K122450	MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS	IYE	2012-10-03
20568	1740167288	K100853	COBAS 8000 MODULAR SERIES ANALYZER	DCF	2010-09-09
349255	1446871865	K073059	PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM	LHN	2007-12-10
349255	1684268079	K072047	MHI-TM2000 LINEAR ACCELERATOR SYSTEM	IYE	2007-08-29
349255	1140864266	K060834	PROBEAT WITH MGCS	LHN	2006-04-19
20568	1317530842	K060373	COBAS 6000 SERIES SYSTEM	CEM	2006-03-13
349255	1533098742	K053280	PROBEAT	LHN	2006-03-09
20568	1537339602	BK110039
20568	1107527317
20568	1496452897
20568	1591483720
20568	1095040831
329583	1107527317
20568	1116639792
343932	1207652943
20568	1210896342
20568	1317530842
20568	1537339602
20568	1551555163
329583	1556227634
20568	1709069782
20568	1722095773
20568	1740167288
20568	1794665845
20568	2005652753

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LHN	14	2026-06-11
JJE	10	1996-06-14
IYE	3	2015-10-21
CFR	1	2019-08-16
JLW	1	2017-01-23
PDJ	1	2016-12-19
DCF	1	2010-09-09
CEM	1	2006-03-13

GUDID#

PROBEAT - The PROBEAT 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.
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 with DSSS 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 DSSS and the cleared PROBEAT is the addition of the Discrete Spot Scanning System (""DSSS""). "
HITACHI HIGH-TECH CORPORATION
2026-04-01
PROBEAT - The PROBEAT-V 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.
HITACHI HIGH-TECH CORPORATION
2026-04-01
PROBEAT - The Extended Range Shifter is an accessory to the PROBEAT-V system that is intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
HITACHI HIGH-TECH CORPORATION
2026-04-01
PROBEAT - The PROBEAT-V 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.
HITACHI HIGH-TECH CORPORATION
2026-04-01
PROBEAT - The PROBEAT-V 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 PROBEAT-V includes optional accessories to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
HITACHI HIGH-TECH CORPORATION
2026-04-01
PROBEAT - The PROBEAT-V with X-ray Limiting Accessory 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.
HITACHI HIGH-TECH CORPORATION
2026-04-01
PROBEAT - The Real Time Image Gating System for Proton Beam Therapy Systems is intended for use with compatible Hitachi proton beam therapy systems and is designed to generate gating signals to deliver a proton beam when the position of a fiducial marker, which is implanted near a tumor and tracked by use of X-ray fluoroscopy, is within a given tolerance from its planned position.
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-CR 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 PROBEAT-CR is a modification to the cleared PROBEAT-V system, for installation at a different clinical site.
HITACHI HIGH-TECH CORPORATION
2026-04-01
PROBEAT - The PROBEAT-FR 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 PROBEAT-FR is a modification to the cleared PROBEAT-CR system, for installation at a different clinical site.
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 HIGH-TECH CORPORATION
2026-04-01