RGC · X-Ray Field Indicator Light (Laser)
Radiology · 21 CFR 892.5780 · Class 1
Overview
| Product Code | RGC |
|---|---|
| Device Name | X-Ray Field Indicator Light (Laser) |
| Regulation | 21 CFR 892.5780 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A light beam patient position indicator is a device that projects a beam of light (incoherent light or laser) to determine the alignment of the patient with a radiation beam. The beam of light is intended to be used during radiologic procedures to ensure proper positioning of the patient and to monitor alignment of the radiation beam with the patient's anatomy.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.
Cleared Devices (0)
No cleared devices on record.
