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FDA 510(k)

MammoScreen

K-Number: K192854 · 2020-03-25

ApplicantTherapixel
Decision Date2020-03-25
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MammoScreen is a medical device manufactured by Therapixel. It received FDA 510(k) clearance on 2020-03-25 under approval number K192854. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MammoScreen?

MammoScreen is a medical device that received FDA 510(k) clearance on 2020-03-25. It is manufactured by Therapixel. The 510(k) number is K192854.

When was MammoScreen approved by the FDA?

MammoScreen received FDA 510(k) clearance on 2020-03-25, under approval number K192854.

What company makes MammoScreen?

MammoScreen is manufactured by Therapixel.

What is the FDA product code for MammoScreen?

The FDA product code for MammoScreen is QDQ.

Other Devices by Therapixel

K211541MammoScreen 2.0 K241561MammoScreen BD K240301MammoScreen® (3) K243685MammoScreen BD K243679MammoScreen® (4)

Related Devices (Code: QDQ)

K182373PowerLook Tomo Detection V2 SoftwareIcad, Inc. K181704TransparaScreenpoint Medical B.V. K192287TransparaScreenpoint Medical B.V. K191994ProFound AI Software V2.1Icad, Inc. K201019Genius AI DetectionHologic, Inc. K193229TransparaScreenpoint Medical B.V.

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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