FDA product code LEK: Transilluminator (Diaphanoscope)
LEK is the FDA product code for transilluminator (diaphanoscope). It is a Class III device, regulated under 21 CFR 892.1990 and reviewed by the Radiology panel. Devices under LEK reach the market by PMA; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for LEK devices, 1 initiated in the last five years.
Definition
Classified August 17, 1995: 60 fr 36639: Classification into Class III for the transilluminator (diaphanoscope or lightscanner) for breast evaluation requires manufacturers of transilluminators to submit safety and effectiveness tests for the device.
Classification
| Field | Value |
|---|---|
| Device name | Transilluminator (Diaphanoscope) |
| Device class | Class III |
| Regulation | 21 CFR 892.1990 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | PMA |
Recalls for LEK devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-05-20.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code LEK?
LEK is the FDA product code for transilluminator (diaphanoscope). It is a Class III device, regulated under 21 CFR 892.1990 and reviewed by the Radiology panel.
What device class is LEK?
Class III, regulation 21 CFR 892.1990. Typical premarket route: PMA.
Have LEK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-05-20.
Next steps
- Run an FDA pathway report with predicate devices for product code LEK
- Run a recall and safety report across every LEK manufacturer
- Watch product code LEK 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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