FDA product code LHR: System, Thermographic, Liquid Crystal (Sole Diagnostic Screen)
LHR is the FDA product code for system, thermographic, liquid crystal (sole diagnostic screen). It is a Class III device, regulated under 21 CFR 884.2982 and reviewed by the Radiology panel. Devices under LHR reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | System, Thermographic, Liquid Crystal (Sole Diagnostic Screen) |
| Device class | Class III |
| Regulation | 21 CFR 884.2982 |
| Review panel | RA — Radiology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | PMA |
Recalls for LHR devices
openFDA lists no recalls for product code LHR.
Frequently asked questions
What is FDA product code LHR?
LHR is the FDA product code for system, thermographic, liquid crystal (sole diagnostic screen). It is a Class III device, regulated under 21 CFR 884.2982 and reviewed by the Radiology panel.
What device class is LHR?
Class III, regulation 21 CFR 884.2982. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LHR
- Run a recall and safety report across every LHR manufacturer
- Watch product code LHR 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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