FDA product code LHQ: System, Telethermographic (Adjunctive Use)
LHQ is the FDA product code for system, telethermographic (adjunctive use). It is a Class I device, regulated under 21 CFR 884.2980 and reviewed by the Radiology panel. FDA has cleared 41 510(k) submissions under LHQ, 4 in the last five years, from 37 different applicants. The average 510(k) review took 136 days (median 98); 163 days on average over the last three years. FDA has posted 1 recall for LHQ devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Telethermographic (Adjunctive Use) |
| Device class | Class I |
| Regulation | 21 CFR 884.2980 |
| Review panel | RA — Radiology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for LHQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 132 |
| 2019 | 1 | 270 |
| 2021 | 2 | 153 |
| 2022 | 2 | 160 |
| 2023 | 1 | 30 |
| 2026 | 1 | 163 |
Compare with all 510(k) review times · Search every LHQ clearance
Top LHQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Usa Therm, Inc. | 2 | 2023-09-14 |
| First Sense Medical, LLC | 2 | 2017-01-09 |
| Micro Health Systems, Inc. | 2 | 2003-03-26 |
| Bales Scientific, Inc. | 2 | 1990-07-13 |
| Neko Health AB | 1 | 2026-05-20 |
32 more applicants have LHQ clearances. See the full list in Caduvo.
Most recent LHQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253911 | Neko Health AB | Derma-2 | 2026-05-20 | 163 |
| K232462 | Usa Therm, Inc. | ThermPix Thermovisual Camera | 2023-09-14 | 30 |
| K213650 | Usa Therm, Inc. | ThermPix Thermovisual Camera | 2022-04-12 | 144 |
| K212965 | Niramai Health Analytix Private Limited | Smile-100 System | 2022-03-10 | 175 |
| K212412 | Medicore Co., Ltd. | IRIS-XP | 2021-09-13 | 41 |
Recalls for LHQ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-01-14.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code LHQ?
LHQ is the FDA product code for system, telethermographic (adjunctive use). It is a Class I device, regulated under 21 CFR 884.2980 and reviewed by the Radiology panel.
What device class is LHQ?
Class I, regulation 21 CFR 884.2980. Typical premarket route: 510(k).
How long does a 510(k) take for product code LHQ?
Across 41 cleared submissions the average was 136 days from receipt to decision (median 98).
Which companies have the most LHQ clearances?
Usa Therm, Inc. (2); First Sense Medical, LLC (2); Micro Health Systems, Inc. (2); Bales Scientific, Inc. (2); Neko Health AB (1).
Have LHQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-01-14.
Next steps
- Run an FDA pathway report with predicate devices for product code LHQ
- Run a recall and safety report across every LHQ manufacturer
- Watch product code LHQ 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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