LNI
10 FDA 510(k) clearances · Product code
85 daysmedian time to decision
826 days90th percentile
10clearances measured
FDA profile
- Official device name
- System, Nuclear Magnetic Resonance Spectroscopic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1000
- Medical specialty
- Radiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2012: 7
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| OASIS MRI SYSTEM (K093044) | Hitachi Medical Systems America, Inc. | 2010-03-16 |
| ECHELON SPECTROSCOPY PACKAGE (K071506) | Hitachi Medical Systems America, Inc. | 2007-06-28 |
| PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI (K011604) | Ge Medical Systems, Inc. | 2001-08-22 |
| EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 (K010129) | Toshiba America Medical Systems, In.C | 2001-04-05 |
| MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM (K003575) | GE Medical Systems | 2001-01-17 |
| MR SPECTROSCOPY PACKAGE (K991568) | Philips Medical Systems (Cleveland), Inc. | 1999-07-19 |
| SAGE 7 (K984167) | GE Medical Systems | 1999-01-12 |
| CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM (K962627) | Siemens Medical Solutions USA, Inc. | 1997-04-03 |
| GYREX 2T-PRESTIGE (K970005) | Elscint, Inc. | 1997-03-28 |
| HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT (K930265) | GE Medical Systems | 1995-04-25 |
Track LNI automatically
Every clearance here is in the API, with alerts when new ones post.