FDA 510(k)

APERTO Lucent MRI System

K-Number: K253862 · 2026-04-06

Decision Date2026-04-06

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

APERTO Lucent MRI System is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2026-04-06 under approval number K253862. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APERTO Lucent MRI System?

APERTO Lucent MRI System is a medical device that received FDA 510(k) clearance on 2026-04-06. It is manufactured by Fujifilm Corporation. The 510(k) number is K253862.

When was APERTO Lucent MRI System approved by the FDA?

APERTO Lucent MRI System received FDA 510(k) clearance on 2026-04-06, under approval number K253862.

What company makes APERTO Lucent MRI System?

APERTO Lucent MRI System is manufactured by Fujifilm Corporation.

What is the FDA product code for APERTO Lucent MRI System?

The FDA product code for APERTO Lucent MRI System is LNH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.