LHQ
- Product code
- LHQ
- Device name
- System, Telethermographic (Adjunctive Use)
- Device class
- Class 1
- 21 CFR
- 21 CFR 884.2980
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 41 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253911 | 2026-05-20 | Neko Health AB | Derma-2 | |
| K232462 | 2023-09-14 | Usa Therm, Inc. | ThermPix Thermovisual Camera |
Official FDA classification page: LHQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).