# LNH: System, Nuclear Magnetic Resonance Imaging

- Device class: 2; regulation: 21 CFR 892.1000; FDA's rule: 510(k) required
- FDA decisions: 1,110
- 510(k) review time 2021–2025: median 102 days (middle half 56–160)
- Recalls: 356 (8 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: 18
- 2018: 29
- 2019: 26
- 2020: 32
- 2021: 27
- 2022: 30
- 2023: 30
- 2024: 26
- 2025: 26
- 2026: 24

## Most-cited predicates
- K121434: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio (2012), cited by 16
- K032428: Magnetom Avanto MR System (2003), cited by 11
- K954355: Advantage Windows 3D with Navigator Option (1995), cited by 10
- K974212: Airis II (1998), cited by 10
- K072237: Magnetom Verio (2007), cited by 9
- K082427: Syngo MR B17 (2008), cited by 9
- K971684: Magnetom Project 047 System (Numaris 3.5 Software) (1997), cited by 9
- K001334: Hitachi Airis II (2000), cited by 8
- K994283: Mri- Magnetic Resonance Analytical Software System (2000), cited by 8
- K945827: Outlook (1995), cited by 8

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