# LHQ: System, Telethermographic (Adjunctive Use)

- Device class: 1; regulation: 21 CFR 884.2980; FDA's rule: 510(k) required
- FDA decisions: 41
- 510(k) review time 2021–2025: median 144 days (middle half 41–175)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2011: 1
- 2012: 1
- 2015: 1
- 2016: 1
- 2017: 2
- 2019: 1
- 2021: 2
- 2022: 2
- 2023: 1
- 2026: 1

## Most-cited predicates
- K171928: Med-Hot Thermal Imaging Systems (2017), cited by 3
- K032350: Infrared Sciences Breastscan IR System (2004), cited by 2
- K020783: Telesis Digital Infrared Thermal Image System, Spectrum 9000MB (2002), cited by 2
- K033967: Telethermographic Camera, Series a, E, S and P (2004), cited by 2
- K971956: CRT2000 Thermographic System (1997), cited by 2
- K982327: Inframetrics Infracam-Med (1998), cited by 2
- K003332: Meditherm MED2000 (2001), cited by 1
- K003130: Regutherm 952 Thermographic System (2001), cited by 1
- K213650: ThermPix Thermovisual Camera (2022), cited by 1
- K181716: InTouch Thermal Camera (2019), cited by 1

Source page: https://510kreport.com/product-code/LHQ
Data by year (CSV): https://510kreport.com/product-code/LHQ.csv