# HEM: Imager, Ultrasonic Obstetric-Gynecologic

- Device class: 2; regulation: 21 CFR 884.2225; FDA's rule: 510(k) required
- FDA decisions: 30
- Recalls: 1 (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)
- 1981: 2
- 1983: 2
- 1984: 2
- 1985: 4
- 1986: 4
- 1988: 2
- 1989: 3
- 1990: 2
- 1991: 2
- 1995: 2

## Most-cited predicates

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