FDA 510(k)

MammoScreen 2.0

K-Number: K211541 · 2021-11-26

Decision Date2021-11-26

Product CodeQDQ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MammoScreen 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Therapixel. It received FDA 510(k) clearance on 2021-11-26 under 510(k) 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. The listed applicant is Therapixel. The 510(k) number is K211541.

When did MammoScreen 2.0 receive FDA 510(k) clearance?

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

Who is the listed applicant for MammoScreen 2.0?

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 2.0?

The FDA product code for MammoScreen 2.0 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 K243679MammoScreen® (4)K241561MammoScreen BD K240301MammoScreen® (3)K192854MammoScreen

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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.