FDA product code LXE: Doppler, Fetal, Ultrasound
LXE is the FDA product code for doppler, fetal, ultrasound. It is a Class II device, regulated under 21 CFR 884.2660 and reviewed by the Radiology panel. Devices under LXE reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Doppler, Fetal, Ultrasound |
| Device class | Class II |
| Regulation | 21 CFR 884.2660 |
| Review panel | RA — Radiology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for LXE devices
openFDA lists no recalls for product code LXE.
Frequently asked questions
What is FDA product code LXE?
LXE is the FDA product code for doppler, fetal, ultrasound. It is a Class II device, regulated under 21 CFR 884.2660 and reviewed by the Radiology panel.
What device class is LXE?
Class II, regulation 21 CFR 884.2660. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code LXE
- Run a recall and safety report across every LXE manufacturer
- Watch product code LXE 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.