510(k) clearance

APERTO Lucent MRI System

FDA 510(k) source

510(k) number

K261283

Applicant

Fujifilm Corporation

Decision date

Sep 16, 2026

Date received

Apr 17, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

LNH

Device type

System, Nuclear Magnetic Resonance Imaging

Device class

Class II

Regulation

21 CFR 892.1000

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

Minato-Ku, JP