FDA product code RCC: C-Arm Fluoroscopic X-Ray System
RCC is the FDA product code for c-arm fluoroscopic x-ray system. It is a Class II device, regulated under 21 CFR 892.1650 and reviewed by the Radiology panel. Devices under RCC reach the market by 510(k); FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for RCC devices.
Definition
Fluoroscopic x-ray system in which the image receptor and x-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. Such a system allows a change in the direction of the beam axis with respect to the patient without moving the patient.
Classification
| Field | Value |
|---|---|
| Device name | C-Arm Fluoroscopic X-Ray System |
| Device class | Class II |
| Regulation | 21 CFR 892.1650 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for RCC devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2020-05-08.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code RCC?
RCC is the FDA product code for c-arm fluoroscopic x-ray system. It is a Class II device, regulated under 21 CFR 892.1650 and reviewed by the Radiology panel.
What device class is RCC?
Class II, regulation 21 CFR 892.1650. Typical premarket route: 510(k).
Have RCC devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2020-05-08.
Next steps
- Run an FDA pathway report with predicate devices for product code RCC
- Run a recall and safety report across every RCC manufacturer
- Watch product code RCC 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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