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FDA 510(k)

MammoScreen® (3)

K-Number: K240301 · 2024-08-01

ApplicantTherapixel
Decision Date2024-08-01
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MammoScreen® (3) is a medical device manufactured by Therapixel. It received FDA 510(k) clearance on 2024-08-01 under approval number K240301. 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® (3)?

MammoScreen® (3) is a medical device that received FDA 510(k) clearance on 2024-08-01. It is manufactured by Therapixel. The 510(k) number is K240301.

When was MammoScreen® (3) approved by the FDA?

MammoScreen® (3) received FDA 510(k) clearance on 2024-08-01, under approval number K240301.

What company makes MammoScreen® (3)?

MammoScreen® (3) is manufactured by Therapixel.

What is the FDA product code for MammoScreen® (3)?

The FDA product code for MammoScreen® (3) is QDQ.

Other Devices by Therapixel

K192854MammoScreen K211541MammoScreen 2.0 K241561MammoScreen BD 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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