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FDA 510(k)

MammoScreen BD

K-Number: K241561 · 2024-10-02

ApplicantTherapixel
Decision Date2024-10-02
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MammoScreen BD is the device name listed in this FDA 510(k) record. The listed applicant is Therapixel. It received FDA 510(k) clearance on 2024-10-02 under 510(k) number K241561. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MammoScreen BD?

MammoScreen BD is a medical device that received FDA 510(k) clearance on 2024-10-02. The listed applicant is Therapixel. The 510(k) number is K241561.

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

MammoScreen BD received FDA 510(k) clearance on 2024-10-02, under 510(k) number K241561.

Who is the listed applicant for MammoScreen BD?

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 BD?

The FDA product code for MammoScreen BD is QIH.

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.

View all 7 devices →

Related Devices (Code: QIH)

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.

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.