KQA · Device, Beam Limiting, X-Ray, Therapeutic
Radiology · 21 CFR 892.5900 · Class 2
Overview
| Product Code | KQA |
|---|---|
| Device Name | Device, Beam Limiting, X-Ray, Therapeutic |
| 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 (4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K914784 | PAPILLION PROCTOSCOPE | Oldelft Corp. of America | Jun 5, 1992 | SESE |
| K885126 | PHILIPS RT250 COLLIMATOR (PK8050) | Perkins Mfg. Co. | Jun 1, 1989 | SESE |
| K844180 | THE MCP-70-SE SYSTEM | Ellis Pharmaceutical Consulting, Inc. | Feb 1, 1985 | SESE |
| K790168 | COLLIMATOR, BILATERIAL | Cmsi | Feb 15, 1979 | SESE |
Top Applicants
- Perkins Mfg. Co. — 1 clearance
- Oldelft Corp. of America — 1 clearance
- Ellis Pharmaceutical Consulting, Inc. — 1 clearance
- Cmsi — 1 clearance
