21 CFR 892.5900 — Generator, Orthovoltage, Therapeutic X-Ray
Radiology (RA) · Subpart F—Therapeutic Devices · § 892.5900
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IYC | Generator, Orthovoltage, Therapeutic X-Ray | 2 | 0 | 3rd Party |
| IYD | Generator, Low Voltage, Therapeutic X-Ray | 2 | 1 | 3rd Party |
| IYH | Generator, Dermatological (Grenz Ray), Therapeutic X-Ray | 2 | 1 | 3rd Party |
| IYI | Collimator, Orthovoltage, Therapeutic X-Ray | 2 | 2 | 3rd Party |
| IYJ | Collimator, Low Voltage, Therapeutic X-Ray | 2 | 0 | 3rd Party |
| IYK | Collimator, High Voltage, Therapeutic X-Ray | 2 | 0 | 3rd Party |
| IYL | Collimator, Dermatological, Therapeutic X-Ray | 2 | 1 | 3rd Party |
| JAD | System, Therapeutic, X-Ray | 2 | 53 | |
| KPZ | Generator, High Voltage, X-Ray, Therapeutic | 2 | 3 | 3rd Party |
| KQA | Device, Beam Limiting, X-Ray, Therapeutic | 2 | 4 | 3rd Party |
