FDA product code RCA: X-Ray Controls - Fluoroscopic
RCA is the FDA product code for x-ray controls - fluoroscopic. It is a Not classified device, reviewed by the Unknown panel. FDA has posted 1 recall for RCA devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | X-Ray Controls - Fluoroscopic |
| Device class | Not classified |
| Medical specialty | Unknown |
Recalls for RCA devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-12-13.
Frequently asked questions
What is FDA product code RCA?
RCA is the FDA product code for x-ray controls - fluoroscopic. It is a Not classified device, reviewed by the Unknown panel.
What device class is RCA?
Not classified.
Have RCA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2012-12-13.
Next steps
- Run an FDA pathway report with predicate devices for product code RCA
- Run a recall and safety report across every RCA manufacturer
- Watch product code RCA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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