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FDA 510(k)

MammoScreen 2.0

K-Number: K211541 · 2021-11-26

ApplicantTherapixel
Decision Date2021-11-26
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MammoScreen 2.0 is a medical device manufactured by Therapixel. It received FDA 510(k) clearance on 2021-11-26 under approval number K211541. 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 2.0?

MammoScreen 2.0 is a medical device that received FDA 510(k) clearance on 2021-11-26. It is manufactured by Therapixel. The 510(k) number is K211541.

When was MammoScreen 2.0 approved by the FDA?

MammoScreen 2.0 received FDA 510(k) clearance on 2021-11-26, under approval number K211541.

What company makes MammoScreen 2.0?

MammoScreen 2.0 is manufactured by Therapixel.

What is the FDA product code for MammoScreen 2.0?

The FDA product code for MammoScreen 2.0 is QDQ.

Other Devices by Therapixel

K192854MammoScreen 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. K192854MammoScreenTherapixel

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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