# K192854: MammoScreen

- Pathway: 510(k) (Traditional)
- Applicant: Therapixel
- Decided: Mar 25, 2020 after 173 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: 2 generations back to DEN180005 (2018). 2 ancestors in all.
4 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)
- K181704: Transpara, Screenpoint Medical B.V. (2018) Summary page 5.

## Most influential descendants
- K211541: MammoScreen 2.0 (2021), 3 descendants of its own
- K240301: MammoScreen® (3) (2024), 2 descendants of its own
- K243679: MammoScreen® (4) (2025), 1 descendant of its own
- K260714: MammoScreen® (5) (2026), 0 descendants of its own

## Indications for use
MammoScreen™ is intended for use as a concurrent reading aid for interpreting physicians, to help identify findings on screening FFDM acquired with compatible mammography systems and assess their level of suspicion. Output of the device includes marks placed on findings on the mammogram and level of suspicion scores. The findings could be soft tissue lesions or calcifications. The level of suspicion score is expressed at the finding level, for each breast and overall for the mammogram. Patient management decisions should not be made solely on the basis of analysis by MammoScreen™.

Source page: https://510kreport.com/device/K192854
Methodology: https://510kreport.com/methodology