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FDA 510(k)

MammoScreen® (4)

K-Number: K243679 · 2025-07-03

ApplicantTherapixel
Decision Date2025-07-03
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MammoScreen® (4) is a medical device manufactured by Therapixel. It received FDA 510(k) clearance on 2025-07-03 under approval number K243679. 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® (4)?

MammoScreen® (4) is a medical device that received FDA 510(k) clearance on 2025-07-03. It is manufactured by Therapixel. The 510(k) number is K243679.

When was MammoScreen® (4) approved by the FDA?

MammoScreen® (4) received FDA 510(k) clearance on 2025-07-03, under approval number K243679.

What company makes MammoScreen® (4)?

MammoScreen® (4) is manufactured by Therapixel.

What is the FDA product code for MammoScreen® (4)?

The FDA product code for MammoScreen® (4) is QDQ.

Other Devices by Therapixel

K192854MammoScreen K211541MammoScreen 2.0 K241561MammoScreen BD K240301MammoScreen® (3) K243685MammoScreen BD

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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