FDA 510(k)

MammoScreen® (5)

K-Number: K260714 · 2026-06-26

Decision Date2026-06-26

Product CodeQDQ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MammoScreen® (5) is the device name listed in this FDA 510(k) record. The listed applicant is Therapixel. It received FDA 510(k) clearance on 2026-06-26 under 510(k) number K260714. 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® (5)?

MammoScreen® (5) is a medical device that received FDA 510(k) clearance on 2026-06-26. The listed applicant is Therapixel. The 510(k) number is K260714.

When did MammoScreen® (5) receive FDA 510(k) clearance?

MammoScreen® (5) received FDA 510(k) clearance on 2026-06-26, under 510(k) number K260714.

Who is the listed applicant for MammoScreen® (5)?

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® (5)?

The FDA product code for MammoScreen® (5) 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.

K243685MammoScreen BD K243679MammoScreen® (4)K241561MammoScreen BD K240301MammoScreen® (3)K211541MammoScreen 2.0 K192854MammoScreen

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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.