FENESTRA HOOK
Device Facts
| Record ID | K841359 |
|---|---|
| Device Name | FENESTRA HOOK |
| Applicant | Treace Medical, Inc. |
| Product Code | IYL · Radiology |
| Decision Date | Jul 18, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.5900 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
