TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE— 510(k) K982157

Name: FDA 510(k) clearance K982157
Creator: U.S. Food and Drug Administration
Published: 1998-09-02

Substantially Equivalent

Field Effects

FDA 510(k) clearance K982157 for TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE, Substantially Equivalent on 1998-09-02. Applicant: Field Effects. Device class: 2.

Clearance details

Applicant: Field Effects
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 1998-06-19
Decision date: 1998-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tyngsborough, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LNH

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K260758 — MAGNETOM Free.Max; MAGNETOM Free.Star2026-09-01
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K254250 — MagicScan-1.5, GreenMR Serenity 1.5T2026-08-17
K253808 — AIR Recon DL2026-08-13
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Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.