Product code RGC

Device name

X-Ray Field Indicator Light (Laser)

Medical specialty

Radiology

Device class

1

Regulation number

892.5780

Review panel

RA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

A laser incorporated in a diagnostic x-ray system that is irradiated onto the film screen area indicating the x-radiation area. The beam is usually scanned to show a rectangular region for patient placement.

Source

FDA openFDA device classification dataset