Company
United StatesHitachi High Tech America, Inc. Radiation Therapy Division, Santa Clara, CA – FDA Inspections
Inspection records and compliance data for Hitachi High Tech America, Inc. Radiation Therapy Division in Santa Clara, California. 4 FDA inspections on record, last inspected August 07, 2026.
Company Profile
This profile covers Hitachi High Tech America, Inc. Radiation Therapy Division based in Santa Clara, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 0
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected February 3, 2014. Last inspected August 7, 2026.
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 7, 2026 | Not classified | Medical Devices & Rad Health | 1333598 |
| March 4, 2022 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1164083 |
| March 9, 2020 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1120603 |
| February 3, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 864449 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Hitachi High Tech America, Inc. Radiation Therapy Division
FEI Number
3003993895
Address
2535 Augustine Dr, Santa Clara, California 95054, United States
Country
United States
ID: e0123e20-f7aa-401a-a40c-79518c8b0ee8