# LNI: System, Nuclear Magnetic Resonance Spectroscopic

- Device class: 2; regulation: 21 CFR 892.1000; FDA's rule: 510(k) required
- FDA decisions: 10
- Recalls: 17 (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)
- 1995: 1
- 1997: 2
- 1999: 2
- 2001: 3
- 2007: 1
- 2010: 1

## Most-cited predicates
- K930265: Hydrogen Spectroscopy Option-Probe #M1040HS/HT (1995), cited by 5
- K003575: Modification to 3.0T Signa VH/I Magnetic Resonance System (2001), cited by 2
- K011604: Prostate Spectroscopy and Imaging Exam (Prose) Software Option  for Mri (2001), cited by 2
- K962627: Clinical Phosphorus Spectroscopy Option/Magnetom Vision System (1997), cited by 2
- K093044: Oasis Mri System (2010), cited by 1
- K991568: MR Spectroscopy Package (1999), cited by 1
- K071506: Echelon Spectroscopy Package (2007), cited by 1

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