HITACHI HIGH-TECH AMERICA, INC. RADIATION THERAPY DIVISION

Contract manufacturer · Santa Clara, CA

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration

3003993895 (openFDA record; or search FDA's registration database)

FEI number

3003993895

Registered for

FDA registration year 2026

Establishment types

Contract manufacturer

Owner or operator

Hitachi High-Tech America, Inc. Radiation Therapy Division (FDA owner/operator no. 10094162)

Registered address

2535 Augustine Dr, Santa Clara, CA 95054

Contract listings

2 device listings, 1 product codes, first listed Jul 20, 2026

Certification

Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.