# IYM: System, Telethermographic, Infrared

- Device class: 3; regulation: 21 CFR 884.2980; FDA's rule: PMA required
- FDA decisions: 8
- 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)
- 1976: 1
- 1980: 2
- 1981: 2
- 1982: 1
- 1986: 2

## Most-cited predicates
- K823041: Jeol Model #JTG-500M (1982), cited by 1
- K812799: DCATS (1981), cited by 1

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