FDA 510(k)

Visage Breast Density

K-Number: K201411 · 2021-01-29

Decision Date2021-01-29

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Visage Breast Density is the device name listed in this FDA 510(k) record. The listed applicant is Visage Imaging GmbH. It received FDA 510(k) clearance on 2021-01-29 under 510(k) number K201411. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Visage Breast Density?

Visage Breast Density is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is Visage Imaging GmbH. The 510(k) number is K201411.

When did Visage Breast Density receive FDA 510(k) clearance?

Visage Breast Density received FDA 510(k) clearance on 2021-01-29, under 510(k) number K201411.

Who is the listed applicant for Visage Breast Density?

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

What is the FDA product code for Visage Breast Density?

The FDA product code for Visage Breast Density is QIH.

Related Devices (Code: QIH)

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Official Source

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