# K152009: DENSEEMAMMO v1.0

- Pathway: 510(k) (Traditional)
- Applicant: Statlife
- Decided: Dec 5, 2016 after 503 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 8 generations back to K904519 (1991). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102556: Volpara, Version 1.3, Matakina Technology Limited (2010) Summary page 4.

## Most influential descendants
- K173574: DenSeeMammo (2018), 0 descendants of its own

## Indications for use
DenSeeMammo is a software application intended for use with digital mammography systems. DenSeeMammo estimates BI-RADS breast density value by analyzing processed digital 2D mammograms using a fully automated comparison procedure. DenSeeMammo provides a BI-RADS breast density 4th Edition category to aid radiologists in the assessment of breast density. DenSeeMammo produces adjunctive information. It is not an interpretive or diagnostic aid when the final assessment of breast density category is made by an MQSA qualified interpreting physician. DenSeeMammo core software has been built and tested on OS X based computers. DenSeeMammo graphical user interface software has been built and tested on Windows, OS X and Linux based computers. DenSeeMammo is compatible for images obtained from GE Senographe Essentials systems.

Source page: https://510kreport.com/device/K152009
Methodology: https://510kreport.com/methodology