Data / Medical devices / System, Telethermographic (Adjunctive Use)
System, Telethermographic (Adjunctive Use) (LHQ): 13 FDA-registered makers in 5 countries
13 establishments in 5 countries are registered with the FDA to make System, Telethermographic (Adjunctive Use) (product code LHQ, Class 1, 21 CFR 884.2980). 12 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 41 510(k) clearances under this code, the latest on May 20, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LHQ
- Device class
- 1
- Regulation
- 884.2980
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| India | 2 |
| South Korea | 1 |
| Sweden | 1 |
| Finland | 1 |
Makers of System, Telethermographic (Adjunctive Use)
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Spectron Ir | Medford, OR, United States | Manufacturer | 2 | October 10, 2003 | 0 | 0 | 0 | api.fda.gov |
| Infrared Cameras Inc. | Beaumont, TX, United States | Manufacturer | 1 | July 11, 2008 | 0 | 0 | 0 | api.fda.gov |
| Med-Hot Thermal Imaging, Inc | Lakeland, FL, United States | Manufacturer | 1 | December 8, 2017 | 0 | 1 | 0 | api.fda.gov |
| Medicore Co. Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 1 | September 13, 2021 | 0 | 0 | 0 | api.fda.gov |
| Meditherm Inc. | Albuquerque, NM, United States | Manufacturer | 1 | February 21, 2001 | 0 | 0 | 0 | api.fda.gov |
| Neko Health AB | Solna, Sweden | Exporter to the US, Manufacturer | 1 | May 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Niramai Health Analytix | Bangalore Karnataka, India | Manufacturer | 1 | March 10, 2022 | 0 | 0 | 0 | api.fda.gov |
| Thermidas OY | TAMPERE Pirkanmaa, Finland | Manufacturer | 1 | January 6, 2021 | 0 | 0 | 0 | api.fda.gov |
| Titronics Research & Development | Tiffin, IA, United States | Manufacturer | 1 | October 10, 2003 | 0 | 0 | 0 | api.fda.gov |
| Ue Lifesciences Inc. | Philadelphia, PA, United States | Specification developer | 1 | February 10, 2012 | 0 | 0 | 0 | api.fda.gov |
| UE LifeSciences (India) Pvt Ltd | Mumbai Maharashtra, India | Manufacturer | 1 | February 10, 2012 | 0 | 0 | 0 | api.fda.gov |
| USA Therm Inc. | Hollywood, FL, United States | Specification developer | 1 | September 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| Design Catapult Manufacturing | Fountain Valley, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.