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FDA 510(k)

APERTO Lucent MRI System

K-Number: K253862 · 2026-04-06

ApplicantFujifilm Corporation
Decision Date2026-04-06
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

APERTO Lucent MRI System is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2026-04-06 under 510(k) 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. The listed applicant is Fujifilm Corporation. The 510(k) number is K253862.

When did APERTO Lucent MRI System receive FDA 510(k) clearance?

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

Who is the listed applicant for APERTO Lucent MRI System?

The FDA 510(k) record lists Fujifilm Corporation as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: LNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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