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