Last synced on 16 May 2025 at 11:05 pm

X-Ray Controls - Fluoroscopic

Page Type
Product Code
Definition
A device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices which control the technique factors of an x-ray exposure for generating x-ray images and presenting them simultaneously and continuously as visible images.
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 RCA is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

X-Ray Controls - Fluoroscopic

Page Type
Product Code
Definition
A device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices which control the technique factors of an x-ray exposure for generating x-ray images and presenting them simultaneously and continuously as visible images.
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 RCA is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.