# IYN: System, Imaging, Pulsed Doppler, Ultrasonic

- Device class: 2; regulation: 21 CFR 892.1550; FDA's rule: 510(k) required
- FDA decisions: 1,190
- 510(k) review time 2021–2025: median 118 days (middle half 85–167)
- Recalls: 134 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 64
- 2018: 59
- 2019: 47
- 2020: 57
- 2021: 46
- 2022: 53
- 2023: 44
- 2024: 50
- 2025: 57
- 2026: 44

## Most-cited predicates
- K053069: Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) (2005), cited by 13
- K060993: GE Logiq P5 and A5 (2006), cited by 12
- K093563: IU22 Ultrasound System and Transducers (2010), cited by 12
- K113690: GE Logiq I, Logiq E and Vivid E (2011), cited by 12
- K151028: LOGIQ e (2015), cited by 12
- K132304: Epiq Diagnostic Ultrasound System (2013), cited by 12
- K133454: Sonosite Edge Ultrasound System (2013), cited by 11
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 (2009), cited by 10
- K003525: Voluson 730 Diagnostic Ultrasound System (2000), cited by 10
- K142160: Logiq E9 Diagnostic Ultrasound System (2014), cited by 10

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