# K243685: MammoScreen BD

- Pathway: 510(k) (Traditional)
- Applicant: Therapixel
- Decided: Aug 22, 2025 after 266 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K904519 (1991). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241561: MammoScreen BD, Therapixel (2024) Summary page 5.

## Indications for use
MammoScreen® BD is a software application intended for use with compatible full-field digital mammography and digital breast tomosynthesis systems. MammoScreen BD evaluates the breast tissue composition to provide an ACR BI-RADS 5th Edition breast density category. The device is intended to be used in the population of asymptomatic women undergoing screening mammography who are at least 40 years old. MammoScreen BD only produces adjunctive information to aid interpreting physicians in the assessment of breast tissue composition. It is not a diagnostic software. Patient management decisions should not be made solely based on analysis by MammoScreen BD.

Source page: https://510kreport.com/device/K243685
Methodology: https://510kreport.com/methodology