FDA product code RCE: Cabinet X-Ray, Industrial
RCE is the FDA product code for cabinet x-ray, industrial. It is a Not classified device, reviewed by the Unknown panel. FDA has posted 21 recalls for RCE devices, 4 initiated in the last five years.
Definition
A cabinet x-ray system used for quality control, non-destructive testing, or some other industrial purpose.
Classification
| Field | Value |
|---|---|
| Device name | Cabinet X-Ray, Industrial |
| Device class | Not classified |
| Medical specialty | Unknown |
| GMP exempt | Yes |
Recalls for RCE devices
21 product recalls in 14 recall events; 4 initiated in the last five years and 6 still open. Most recent: 2026-07-24.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2025 | 2 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code RCE?
RCE is the FDA product code for cabinet x-ray, industrial. It is a Not classified device, reviewed by the Unknown panel.
What device class is RCE?
Not classified.
Have RCE devices been recalled?
Yes: 21 product recalls across 14 recall events; the most recent began 2026-07-24.
Next steps
- Run an FDA pathway report with predicate devices for product code RCE
- Run a recall and safety report across every RCE manufacturer
- Watch product code RCE 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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