FDA 510(k)

MammoScreen® (4)

K-Number: K243679 · 2025-07-03

Decision Date2025-07-03

Product CodeQDQ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MammoScreen® (4) is the device name listed in this FDA 510(k) record. The listed applicant is Therapixel. It received FDA 510(k) clearance on 2025-07-03 under 510(k) 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. The listed applicant is Therapixel. The 510(k) number is K243679.

When did MammoScreen® (4) receive FDA 510(k) clearance?

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

Who is the listed applicant for MammoScreen® (4)?

The FDA 510(k) record lists Therapixel as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Therapixel as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260714MammoScreen® (5)K243685MammoScreen BD K241561MammoScreen BD K240301MammoScreen® (3)K211541MammoScreen 2.0 K192854MammoScreen

View all 7 devices →

Related Devices (Code: QDQ)

K260898Transpara (2.1.0)Screenpoint Medical B.V.K260086CadAI-B DxBeamWorks, Inc.K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.K260714MammoScreen® (5)Therapixel K253825Saige-DxDeepHealth, Inc.K253682DeepHealth ProstateAIQuantib 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.