FDA product code RBY: X-Ray Fluorescence
RBY is the FDA product code for x-ray fluorescence. It is a Not classified device, reviewed by the Unknown panel. FDA has posted 5 recalls for RBY devices.
Definition
An x-ray system for x-ray fluorescence and used in a laboratory environment.
Classification
| Field | Value |
|---|---|
| Device name | X-Ray Fluorescence |
| Device class | Not classified |
| Medical specialty | Unknown |
| GMP exempt | Yes |
Recalls for RBY devices
5 product recalls in 5 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2017-07-11.
| Year | Recalls |
|---|---|
| 2017 | 2 |
Frequently asked questions
What is FDA product code RBY?
RBY is the FDA product code for x-ray fluorescence. It is a Not classified device, reviewed by the Unknown panel.
What device class is RBY?
Not classified.
Have RBY devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2017-07-11.
Next steps
- Run an FDA pathway report with predicate devices for product code RBY
- Run a recall and safety report across every RBY manufacturer
- Watch product code RBY 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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