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 a medical device manufactured by Visage Imaging GmbH. It received FDA 510(k) clearance on 2021-01-29 under approval 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. It is manufactured by Visage Imaging GmbH. The 510(k) number is K201411.

When was Visage Breast Density approved by the FDA?

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

What company makes Visage Breast Density?

Visage Breast Density is manufactured by Visage Imaging GmbH.

What is the FDA product code for Visage Breast Density?

The FDA product code for Visage Breast Density is QIH.

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Official Source

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