21 CFR 892.5050 — Cyclotron, Medical
Radiology (RA) · Subpart F—Therapeutic Devices · § 892.5050
Identification
A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in 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. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IWK | Cyclotron, Medical | 2 | 0 | |
| IWM | Synchrotron, Medical | 2 | 1 | |
| IYE | Accelerator, Linear, Medical | 2 | 731 | |
| IYG | Betatron, Medical | 2 | 0 | |
| JAE | Microtron, Medical | 2 | 0 | |
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 2 | 91 | |
| MUJ | System, Planning, Radiation Therapy Treatment | 2 | 252 | |
| MWW | Accessory - Film Dosimetry System | 2 | 0 | |
| NZT | Dosimeter, Ionizing Radiation, Implanted | 2 | 7 | Implant |
