IYI · Collimator, Orthovoltage, Therapeutic X-Ray
Radiology · 21 CFR 892.5900 · Class 2
Overview
| Product Code | IYI |
|---|---|
| Device Name | Collimator, Orthovoltage, Therapeutic X-Ray |
| Regulation | 21 CFR 892.5900 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K914821 | CRS RADIATION BEAM SCANNER | Consolidated Radiation Services, Inc. | Dec 17, 1992 | SESE |
| K900932 | 37-702 AND 37-703 PC RAINBOW | Victoreen, Inc. | Dec 5, 1990 | SESE |
Top Applicants
- Victoreen, Inc. — 1 clearance
- Consolidated Radiation Services, Inc. — 1 clearance
