# K232096: Transpara Density 1.0.0

- Pathway: 510(k) (Traditional)
- Applicant: Screenpoint Medical B.V.
- Decided: Dec 11, 2023 after 151 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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 5.

## Indications for use
Transpara Density is a software application intended for use with data from compatible digital mammography and digital breast tomosynthesis systems. Transpara Density utilises deep learning artificial intelligence algorithms to automatically determine volumetric breast density (VBD), breast volume, and an ACR BI-RADS 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. It is not a diagnostic aid.

Source page: https://510kreport.com/device/K232096
Methodology: https://510kreport.com/methodology