MammoScreen BD
K-Number: K243685 · 2025-08-22
ApplicantTherapixel
Decision Date2025-08-22
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
MammoScreen BD is a medical device manufactured by Therapixel. It received FDA 510(k) clearance on 2025-08-22 under approval number K243685. 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 2025-08-22. It is manufactured by Therapixel. The 510(k) number is K243685.
When was MammoScreen BD approved by the FDA?
MammoScreen BD received FDA 510(k) clearance on 2025-08-22, under approval number K243685.
What company makes MammoScreen BD?
MammoScreen BD is manufactured by Therapixel.
What is the FDA product code for MammoScreen BD?
The FDA product code for MammoScreen BD is QIH.
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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.