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FDA 510(k)

APERTO Lucent MRI System

K-Number: K233629 · 2024-05-10

ApplicantFUJIFILM Healthcare Americas Corporation
Decision Date2024-05-10
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

APERTO Lucent MRI System is a medical device manufactured by FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2024-05-10 under approval number K233629. 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 2024-05-10. It is manufactured by FUJIFILM Healthcare Americas Corporation. The 510(k) number is K233629.

When was APERTO Lucent MRI System approved by the FDA?

APERTO Lucent MRI System received FDA 510(k) clearance on 2024-05-10, under approval number K233629.

What company makes APERTO Lucent MRI System?

APERTO Lucent MRI System is manufactured by FUJIFILM Healthcare Americas 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.

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