FDA product code LNB: Applicator, Hyperthermia, Deep Heating, Ultrasound
LNB is the FDA product code for applicator, hyperthermia, deep heating, ultrasound. It is a Class III device, reviewed by the Radiology panel. Devices under LNB 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 | Applicator, Hyperthermia, Deep Heating, Ultrasound |
| Device class | Class III |
| Review panel | RA — Radiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LNB devices
openFDA lists no recalls for product code LNB.
Frequently asked questions
What is FDA product code LNB?
LNB is the FDA product code for applicator, hyperthermia, deep heating, ultrasound. It is a Class III device, reviewed by the Radiology panel.
What device class is LNB?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LNB
- Run a recall and safety report across every LNB manufacturer
- Watch product code LNB 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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