X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R
Device Facts
| Record ID | K871116 |
|---|---|
| Device Name | X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R |
| Applicant | X-Cel X-Ray Corp. |
| Product Code | IYH · Radiology |
| Decision Date | May 14, 1987 |
| 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.
