# K182310: Volpara Imaging Software

- Pathway: 510(k) (Special)
- Applicant: Volpara Health Technologies Limited
- Decided: Sep 21, 2018 after 28 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: 10 generations back to K904519 (1991). 22 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153427: Volpara Imaging Software, Matakina Technology, Ltd. (2016) Summary page 4.

## Most influential descendants
- K232096: Transpara Density 1.0.0 (2023), 0 descendants of its own
- K211279: Volpara Imaging Software (2021), 0 descendants of its own

## Indications for use
Volpara is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis. Volpara calculates and quantifies a density map and from that determines volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Volpara provides these numerical values along with a BI-RADS breast density 4th or 5th Edition category to aid health care professionals in the assessment of breast tissue composition. Volpara is not an interpretive or diagnostic aid and should be used only as adjunctive information when the final assessment of breast density category is made by an MQSA qualified interpreting physician.

Source page: https://510kreport.com/device/K182310
Methodology: https://510kreport.com/methodology