Product code LNI— Radiology
CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM
- Classification name
- System, Nuclear Magnetic Resonance Spectroscopic
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Total cleared
- 10
- First cleared
- Most recent
Market context for product code LNI
FDA has cleared devices under product code LNI between 1995 and 2010, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2010
- 2007
- 2001
- 1999
- 1997
- 1995
Top applicants under product code LNI
Recent clearances under product code LNI
- K093044 — OASIS MRI SYSTEM
- K071506 — ECHELON SPECTROSCOPY PACKAGE
- K011604 — PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI
- K010129 — EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3
- K003575 — MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
- K991568 — MR SPECTROSCOPY PACKAGE
- K984167 — SAGE 7
- K962627 — CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM
- K970005 — GYREX 2T-PRESTIGE
- K930265 — HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT
Data sourced from openFDA. This site is unofficial and independent of the FDA.