FDA Device Establishments · JSON-LD · Markdown
FEI 1000162206 · Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 1000162206 |
|---|---|
| Owner / Operator | HITACHI HIGH-TECH CORP. (#9049564) |
| Address | 226-44-141-1, WAKASHIBA, KASHIWA-SHI Chiba, 277-0871, JP |
| Mandatory US Agent | HITACHI HIGH-TECH AMERICA, INC. RADIATION THERAPY DIVISION |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | IYE |
| Regulation § (21 CFR) | 892.5050 |
| Proprietary names | MHI-TM2000 Linear Accelerator System, VERO, Imavis |
Source: openFDA. Public-domain (CC0).