RAD II SIMULATOR
Device Facts
| Record ID | K834281 |
|---|---|
| Device Name | RAD II SIMULATOR |
| Applicant | Haynes Radiation Ltd., Inc. |
| Product Code | KPQ · Radiology |
| Decision Date | Dec 29, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.5840 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
