HITACHI HIGH-TECH CORP., KASHIWANOHA

FDA Device Registration & Listing · KASHIWA-SHI Chiba, JP · Registration 1000162206

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1000162206
FEI Number
1000162206
Entity Name
HITACHI HIGH-TECH CORP., KASHIWANOHA
City/State/Country
KASHIWA-SHI Chiba, JP
Establishment Address
226-44-141-1, WAKASHIBA, KASHIWA-SHI Chiba 277-0871, JP
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
HITACHI HIGH-TECH CORP. (Owner Number: 9049564)
Owner / Operator Contact Address
1-17-1 Toranomon,, --, Minato-ku, JP-13 105-6409, JP
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K232032
PMA Number
N/A

All Registered Proprietary Names

EXTENDED RANGE SHIFTER FOR PROBEAT-V Small Field Applicator MHI-TM2000 Linear Accelerator System, VERO, Imavis PROBEAT-CR PROBEAT-V PROTON BEAM THERAPY SYSTEM WITH X-RAY LIMITING ACCESSORY PROBEAT-V MHI-TM2000 LINEAR ACCELERATOR SYSTEM PROBEAT WITH MGCS PROBEAT-CR PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM PROBEAT-FR

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2026-03-18
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2026-03-18
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2026-03-18
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2026-06-12
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2026-03-18
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2026-03-18
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2026-03-18
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2026-03-18
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2026-03-18
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2026-03-18
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2026-03-17

Official Correspondent

No official correspondent registered.

US Agent Details

Yuki Terakado Business: HITACHI HIGH-TECH AMERICA, INC. RADIATION THERAPY DIVISION Email: yuki.terakado.ty@hitachi-hightech.com Phone: (408) 9866300

Related Public Records

Same Entity

HITACHI HIGH-TECH CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3014840402 Hitachi High-Tech Corp., Omuta Center Omuta-shi Fukuoka, JP
9610865 HITACHI HIGH-TECH CORP., Ome Works Ome-Shi Tokyo, JP
3031570369 HITACHI HIGH-TECH CORP., Musashimurayama Center Musashimurayama Tokyo, JP
9614673 HITACHI HIGH-TECH CORP., NAKA DIVISION Hitachinaka-shi Ibaraki, JP

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K071992 Varian Medical Systems HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) 2007-08-15
K253962 Radformation, Inc. ClearCheck (RADCC V2.7) 2026-04-03
K003779 Arplay Medical S.A. IMMOBILIZATION SYSTEM FOR ENT 2001-07-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2009 Intraop Medical Corporation 2
Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site.
Z-0004-2019 Varian Medical Systems 2
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019 Varian Medical Systems 2
VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015 N/A 2
Proteus 235 Proton Therapy System for cancer treatment.
Z-0035-2012 Accuray Incorporated 2
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000162206. Last updated year: 2026. Please use registration number 1000162206 when referencing this establishment in official correspondence.
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