# Hitachi High-Tech America, Inc. Radiation Therapy Division (contract manufacturer, Santa Clara, CA): 2 new FDA device listings, incl. system, radiation therapy, charged-particle, medical

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | Hitachi High-Tech America, Inc. Radiation Therapy Division |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Santa Clara, CA, US |
| New listings | 2 |
| Devices | System, Radiation Therapy, Charged-Particle, Medical |
| Product codes | LHN |
| Device classes | Class II |
| Medical specialties | Radiology |
| First new listing | 2026-07-20 |
| Latest new listing | 2026-08-05 |
| FDA registration number | 3003993895 |
| Registration expires | 2026-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.