# K132742: M-VU Breast Density

- Pathway: 510(k) (Traditional)
- Applicant: Vucomp, Inc.
- Decided: Dec 3, 2013 after 91 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.
11 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082483: Quantra, Hologic, Inc. (2008) Summary page 1.
- K102556: Volpara, Version 1.3, Matakina Technology Limited (2010) Summary page 1.

## Most influential descendants
- K170540: DM-Density (2018), 7 descendants of its own
- K192973: densitas densityai (2020), 5 descendants of its own
- K202013: WRDensity by Whiterabbit.ai (2020), 2 descendants of its own
- K180125: PowerLook Density Assessment Software (2018), 2 descendants of its own
- K241561: MammoScreen BD (2024), 1 descendant of its own

## Indications for use
M-Vu Breast Density is a software application intended for use with digital mammography systems. M-Vu Breast Density calculates breast density as a ratio of fibroglandular tissue and total breast area estimates. M-Vu Breast Density provides these numerical values for each breast as well as a density category to aid radiologists in the assessment of breast tissue composition. M-Vu Breast Density produces adjunctive information. It is not an interpretive or diagnostic aid.

Source page: https://510kreport.com/device/K132742
Methodology: https://510kreport.com/methodology