Last synced on 16 May 2025 at 11:05 pm

X-Ray Field Indicator Light Field (Non-Laser)

Page Type
Product Code
Definition
A noncoherent light source 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.
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code RGU is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

X-Ray Field Indicator Light Field (Non-Laser)

Page Type
Product Code
Definition
A noncoherent light source 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.
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code RGU is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.