FDA product code NCL: Imager, Breast, Electrical Impedance
NCL is the FDA product code for imager, breast, electrical impedance. It is a Class III device, reviewed by the Radiology panel. Devices under NCL reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Imager, Breast, Electrical Impedance |
| Device class | Class III |
| Review panel | RA — Radiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for NCL devices
openFDA lists no recalls for product code NCL.
Frequently asked questions
What is FDA product code NCL?
NCL is the FDA product code for imager, breast, electrical impedance. It is a Class III device, reviewed by the Radiology panel.
What device class is NCL?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code NCL
- Run a recall and safety report across every NCL manufacturer
- Watch product code NCL 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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