Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003993895

FEI Number

3003993895

Entity Name

HITACHI HIGH-TECH AMERICA, INC. RADIATION THERAPY DIVISION

City/State/Country

Santa Clara, CA, US

Establishment Address

2535 Augustine Dr, Santa Clara, CA 95054, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hitachi High-Tech America, Inc. Radiation Therapy Division (Owner Number: 10094162)

Owner / Operator Contact Address

2535 Augustine Dr., Santa Clara, CA 95054, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K053280

PMA Number

N/A

All Registered Proprietary Names

PROBEAT

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	2025-11-17

Official Correspondent

Yuki Terakado

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hitachi High-Tech America, Inc. Radiation Therapy Division

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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.

Similar Registrations

Registration Number	Establishment Name	Location
3016872563	EHMET HEALTH	Plymouth, MI, US
3015232217	ELEKTA SOLUTIONS AB	STOCKHOLM, SE
8043933	BRAINLAB SE	Munich Bavaria, DE
3010658895	Varian Medical Systems Particle Therapy GmbH & Co. KG	Troisdorf North Rhine-Westphalia, DE
8031557	ANZAI MEDICAL CO, LTD.	SHINAGAWA-KU Tokyo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003993895. Last updated year: 2026. Please use registration number 3003993895 when referencing this establishment in official correspondence.