# K211279: Volpara Imaging Software

- Pathway: 510(k) (Special)
- Applicant: Volpara Health Technologies Limited
- Decided: Jul 27, 2021 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: 11 generations back to K904519 (1991). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182310: Volpara Imaging Software, Volpara Health Technologies Limited (2018) Summary page 4.

## Indications for use
Volpara Imaging Software is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis. Volpara Imaging Software 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 Imaging Software provides these numerical values along with a BI-RADS breast density 4th or 5th Edition category and quality assurance metrics (i.e., dose and pressure) to aid healthcare professionals in the assessment of breast composition. Volpara Imaging Software is not a 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/K211279
Methodology: https://510kreport.com/methodology