PROWESS 2000
Device Facts
| Record ID | K884261 |
|---|---|
| Device Name | PROWESS 2000 |
| Applicant | Small Systems Group, Inc. |
| Product Code | KPQ · Radiology |
| Decision Date | Aug 4, 1989 |
| 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.
