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FDA 510(k)

FLAT PANEL DETECTOR, MODEL FDR D-EVO

K-Number: K100762 · 2010-07-15

ApplicantFujifilm Medical Systems U.S.A, Inc.
Decision Date2010-07-15
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FLAT PANEL DETECTOR, MODEL FDR D-EVO is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2010-07-15 under 510(k) number K100762. 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 FLAT PANEL DETECTOR, MODEL FDR D-EVO?

FLAT PANEL DETECTOR, MODEL FDR D-EVO is a medical device that received FDA 510(k) clearance on 2010-07-15. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K100762.

When did FLAT PANEL DETECTOR, MODEL FDR D-EVO receive FDA 510(k) clearance?

FLAT PANEL DETECTOR, MODEL FDR D-EVO received FDA 510(k) clearance on 2010-07-15, under 510(k) number K100762.

Who is the listed applicant for FLAT PANEL DETECTOR, MODEL FDR D-EVO?

The FDA 510(k) record lists Fujifilm Medical Systems U.S.A, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLAT PANEL DETECTOR, MODEL FDR D-EVO?

The FDA product code for FLAT PANEL DETECTOR, MODEL FDR D-EVO 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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