# IYO: System, Imaging, Pulsed Echo, Ultrasonic

- Device class: 2; regulation: 21 CFR 892.1560; FDA's rule: 510(k) required
- FDA decisions: 897
- 510(k) review time 2021–2025: median 157 days (middle half 65–233)
- Recalls: 50 (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)
- 2017: 19
- 2018: 14
- 2019: 13
- 2020: 11
- 2021: 15
- 2022: 5
- 2023: 11
- 2024: 10
- 2025: 7
- 2026: 10

## Most-cited predicates
- K961459: Level 10 Hdi (1997), cited by 16
- K071217: Bladderscan Bvi 9400 Ultrasound (2007), cited by 12
- K042540: Philips IU22 Ultrasound System (2004), cited by 12
- K102991: M5 Diagnostic Ultrasound System (2010), cited by 8
- K131690: M7/M7T Diagnostic Ultrasound System (2013), cited by 8
- K973767: Harmonic Imaging with Contrast (1997), cited by 8
- K063085: Modification to Acuson Sequoia Ultrasound System (2006), cited by 8
- K082185: GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2 (2008), cited by 8
- K072797: GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact Ultrasound (2007), cited by 7
- K070907: Interson Usb Ultrasound Probe System (2007), cited by 7

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