# K102556: Volpara, Version 1.3

- Pathway: 510(k) (Traditional)
- Applicant: Matakina Technology Limited
- Decided: Oct 7, 2010 after 30 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: 7 generations back to K904519 (1991). 19 ancestors in all.
24 later devices descend from it; 6 cite it directly.
0 of 44 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.

## Most influential descendants
- K132742: M-VU Breast Density (2013), 11 descendants of its own
- K152028: Volpara Imaging Software (2015), 8 descendants of its own
- K170540: DM-Density (2018), 7 descendants of its own
- K192973: densitas densityai (2020), 5 descendants of its own
- K153427: Volpara Imaging Software (2016), 3 descendants of its own

## Indications for use
Volpara is a software application intended for use with digital mammography systems. Volpara calculates volumetric breast density -as a ratio of fibroglandular tissue and total breast volume estimates. Volpara provides these numerical values fbr each image to aid radiologists in the assessment of breast tissue composition. Volpara produces adjunctive information. It is not an interpretive or diagnostic aid. Volpara is a software application which runs on Windows or Linux-based computers.

Source page: https://510kreport.com/device/K102556
Methodology: https://510kreport.com/methodology