510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LNIClass II

System, Nuclear Magnetic Resonance Spectroscopic

21 CFR 892.1000 / Radiology
FDA source (opens on fda.gov)

LNI is the FDA product code for System, Nuclear Magnetic Resonance Spectroscopic, a class II device type, regulated under 21 CFR 892.1000. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 17 recalls.

Classification record

Product code
LNI
Device name
System, Nuclear Magnetic Resonance Spectroscopic
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
10
Ingested recalls
17

Clearances, product code LNI

By decision year
10 clearances under product code LNI with a decision year between 1995 and 2010, 2001 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code LNI by decision year
YearClearances
19951
19972
19992
20013
20071
20101

Applicants with the most clearances

Product code LNI
Applicants holding the most 510(k) clearances under product code LNI
ApplicantClearances
GE Healthcare4
FUJIFILM Healthcare Americas Corporation2
Elscint, Inc.1
Philips North America LLC1
Siemens Medical Solutions USA, Inc.1
Toshiba America Medical Systems, In.C1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 48 companies shown, in name order