X-Ray Field Indicator Light (Laser)
The X-Ray Field Indicator Light (Laser) is a laser incorporated into a diagnostic x-ray system that projects onto the field being imaged to assist in aligning the x-ray beam with the intended target area. It falls under the medical specialty of Radiology with product code RGC and regulation number 892.5780. This device is Class 1, meaning it is subject to general controls, which are the least stringent regulatory requirements, reflecting the device's low risk profile. It is not flagged as an implant or life-sustaining device, and no premarket submission is required. This laser accessory aids in the safe and accurate positioning of diagnostic x-ray equipment.
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Basic Information
- Product Code
- RGC
- Device Class
- FDA class 1
- Regulation Number
- 892.5780
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 4
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.