510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K982157Substantially Equivalent

Trex MRI Magnetic Resonance Diagnostic Device

Field Effects, Tyngsborough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982157 is the FDA 510(k) clearance record for TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE, a class II device, cleared for Field Effects on under FDA product code LNH (System, Nuclear Magnetic Resonance Imaging). FDA records list one 510(k) clearance for Field Effects. As of , FDA records show no recalls naming K982157.

Clearance record

Decision date
Received
(75 days to decision)
Product code
LNH System, Nuclear Magnetic Resonance Imaging
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Field Effects 300 Vesper Executive Park, Tyngsborough MA
510(k) summary
Summary
Third party review
No

Clearances, product code LNH

Trailing 12 months
26 clearances under product code LNH in the twelve months to October 2026, March 2026 the highest month at 6.
Show the numbers
Monthly 510(k) clearances under FDA product code LNH, trailing twelve months
MonthClearances
November 20251
December 20253
January 20261
February 20264
March 20266
April 20261
May 20261
June 20260
July 20262
August 20263
September 20263
October 20261