LNI · Class II · 21 CFR 892.1000

FDA Product Code LNI: System, Nuclear Magnetic Resonance Spectroscopic

Leading manufacturers include GE Medical Systems, Hitachi Medical Systems America, Inc. and Toshiba America Medical Systems, In.C.

10
Total
10
Cleared
173d
Avg days
1995
Since

FDA 510(k) Cleared System, Nuclear Magnetic Resonance Spectroscopic Devices (Product Code LNI)

10 devices
1–10 of 10
Cleared Mar 16, 2010
OASIS MRI SYSTEM
K093044
Hitachi Medical Systems America, Inc.
Radiology · 167d
Cleared Jun 28, 2007
ECHELON SPECTROSCOPY PACKAGE
K071506
Hitachi Medical Systems America, Inc.
Radiology · 27d
Cleared Aug 22, 2001
PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI
K011604
Ge Medical Systems, Inc.
Radiology · 90d
Cleared Apr 05, 2001
EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3
K010129
Toshiba America Medical Systems, In.C
Radiology · 79d
Cleared Jan 17, 2001
MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
K003575
GE Medical Systems
Radiology · 58d
Cleared Jul 19, 1999
MR SPECTROSCOPY PACKAGE
K991568
Philips Medical Systems (Cleveland), Inc.
Radiology · 75d
Cleared Jan 12, 1999
SAGE 7
K984167
GE Medical Systems
Radiology · 53d
Cleared Apr 03, 1997
CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM
K962627
Siemens Medical Solutions USA, Inc.
Radiology · 272d
Cleared Mar 28, 1997
GYREX 2T-PRESTIGE
K970005
Elscint, Inc.
Radiology · 85d
Cleared Apr 25, 1995
HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT
K930265
GE Medical Systems
Radiology · 826d

About Product Code LNI - Regulatory Context