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FDA 510(k)

FDR SE Lite

K-Number: K192440 · 2019-11-01

ApplicantFujifilm Corporation
Decision Date2019-11-01
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FDR SE Lite is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2019-11-01 under 510(k) number K192440. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FDR SE Lite?

FDR SE Lite is a medical device that received FDA 510(k) clearance on 2019-11-01. The listed applicant is Fujifilm Corporation. The 510(k) number is K192440.

When did FDR SE Lite receive FDA 510(k) clearance?

FDR SE Lite received FDA 510(k) clearance on 2019-11-01, under 510(k) number K192440.

Who is the listed applicant for FDR SE Lite?

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 FDR SE Lite?

The FDA product code for FDR SE Lite is MQB.

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Related Devices (Code: MQB)

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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