# K240301: MammoScreen® (3)

- Pathway: 510(k) (Traditional)
- Applicant: Therapixel
- Decided: Aug 1, 2024 after 182 days
- Product code: QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer)
- Device class: 2
- Regulation: 21 CFR 892.2090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN180005 (2018). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211541: MammoScreen 2.0, Therapixel (2021) Summary page 4.

## Most influential descendants
- K243679: MammoScreen® (4) (2025), 1 descendant of its own
- K260714: MammoScreen® (5) (2026), 0 descendants of its own

## Indications for use
MammoScreen® 3 is a concurrent reading and reporting aid for physicians interpreting screening mammograms. It is intended for use with compatible full-field digital mammography and digital breast tomosynthesis systems. The device can also use compatible prior examinations in the analysis. Output of the device includes graphical marks of findings as soft-tissue lesions or calcifications on mammograms along with their level of suspicion scores. The lesion type is characterized as mass/asymmetry, distortion, or calcifications for each detected finding. The level of suspicion score is expressed at the finding level, for each breast, and overall for the mammogram. The location of findings, including quadrant, depth, and distance from the nipple, is also provided. This adjunctive information is intended to assist interpreting physicians during reporting. Patient management decisions should not be made solely based on the analysis by MammoScreen 3.

Source page: https://510kreport.com/device/K240301
Methodology: https://510kreport.com/methodology