DeviceClearance

Product code LNH— Radiology

MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY

Classification name
System, Nuclear Magnetic Resonance Imaging
Device class
Class 2
Regulation
21 CFR 892.1000
Advisory panel
Radiology
Total cleared
1,104
First cleared
Most recent

Market context for product code LNH

FDA has cleared 1,104 devices under product code LNH between 1988 and 2026, filed by 211 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

last 15 years

Top applicants under product code LNH

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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code LNH

1–100 of 1,104

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