FDA product code LHM: System, Thermographic, Liquid Crystal
LHM is the FDA product code for system, thermographic, liquid crystal. It is a Class I device, regulated under 21 CFR 884.2982 and reviewed by the Radiology panel. FDA has cleared 1 510(k) submission under LHM. The average 510(k) review took 83 days (median 83).
Classification
| Field | Value |
|---|---|
| Device name | System, Thermographic, Liquid Crystal |
| Device class | Class I |
| Regulation | 21 CFR 884.2982 |
| Review panel | RA — Radiology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every LHM clearance
Top LHM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Thermascan, Inc. | 1 | 1987-10-20 |
Most recent LHM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K872962 | Thermascan, Inc. | BREAST-SCAN(TM) | 1987-10-20 | 83 |
Recalls for LHM devices
openFDA lists no recalls for product code LHM.
Frequently asked questions
What is FDA product code LHM?
LHM is the FDA product code for system, thermographic, liquid crystal. It is a Class I device, regulated under 21 CFR 884.2982 and reviewed by the Radiology panel.
What device class is LHM?
Class I, regulation 21 CFR 884.2982. Typical premarket route: 510(k).
How long does a 510(k) take for product code LHM?
Across 1 cleared submissions the average was 83 days from receipt to decision (median 83).
Which companies have the most LHM clearances?
Thermascan, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LHM
- Run a recall and safety report across every LHM manufacturer
- Watch product code LHM 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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