# MOS: Coil, Magnetic Resonance, Specialty

- Device class: 2; regulation: 21 CFR 892.1000; FDA's rule: 510(k) required
- FDA decisions: 491
- 510(k) review time 2021–2025: median 60 days (middle half 25–105)
- Recalls: 31 (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: 9
- 2018: 10
- 2019: 3
- 2020: 5
- 2021: 4
- 2022: 11
- 2023: 10
- 2024: 10
- 2025: 3
- 2026: 10

## Most-cited predicates
- K980157: Premier 7000 CTL Spine Coil (1998), cited by 8
- K001870: Millennium 9000 Phased Array Neurovascular Coil (2000), cited by 7
- K001209: Insight Plus 9000 Phased Array Torso and Pelvis Coil (2000), cited by 7
- K013159: HRH-63-8 Head Array Coil (2001), cited by 4
- K121362: 1.5T 16CH Flex Speeder Large (2012), cited by 4
- K041481: Model BBC-127 Biopsy Breast Coil (2004), cited by 4
- K994345: Magna 5000 Phased Array CTL Spine Coil (2000), cited by 4
- K032576: Biopsy Breast Coil, Model BBC (2003), cited by 4
- K972205: Alpha 7000 Quadrature Wrist Coil (1997), cited by 4
- K021330: Magnetom Trio Quadrature TX/RX Head Coil (2002), cited by 4

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