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FDA 510(k)

BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY

K-Number: K033859 · 2004-06-02

ApplicantBarco NV Barcoview
Decision Date2004-06-02
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY is the device name listed in this FDA 510(k) record. The listed applicant is Barco NV Barcoview. It received FDA 510(k) clearance on 2004-06-02 under 510(k) number K033859. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY?

BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY is a medical device that received FDA 510(k) clearance on 2004-06-02. The listed applicant is Barco NV Barcoview. The 510(k) number is K033859.

When did BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY receive FDA 510(k) clearance?

BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY received FDA 510(k) clearance on 2004-06-02, under 510(k) number K033859.

Who is the listed applicant for BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY?

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

What is the FDA product code for BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY?

The FDA product code for BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY is LLZ.

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Other records listing Barco NV Barcoview as applicant

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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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