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FDA 510(k)

MammoScreen

K-Number: K192854 · 2020-03-25

ApplicantTherapixel
Decision Date2020-03-25
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MammoScreen is the device name listed in this FDA 510(k) record. The listed applicant is Therapixel. It received FDA 510(k) clearance on 2020-03-25 under 510(k) number K192854. 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?

MammoScreen is a medical device that received FDA 510(k) clearance on 2020-03-25. The listed applicant is Therapixel. The 510(k) number is K192854.

When did MammoScreen receive FDA 510(k) clearance?

MammoScreen received FDA 510(k) clearance on 2020-03-25, under 510(k) number K192854.

Who is the listed applicant for MammoScreen?

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?

The FDA product code for MammoScreen 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 BDK243679MammoScreen® (4)K241561MammoScreen BDK240301MammoScreen® (3)K211541MammoScreen 2.0

View all 7 devices →

Related Devices (Code: QDQ)

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.

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)TherapixelK253825Saige-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.

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