# K202013: WRDensity by Whiterabbit.ai

- Pathway: 510(k) (Traditional)
- Applicant: Whiterabbit.Ai, Inc.
- Decided: Oct 30, 2020 after 101 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.
2 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192973: densitas densityai, Densitas, Inc. (2020) Summary page 4.

## Most influential descendants
- K241561: MammoScreen BD (2024), 1 descendant of its own
- K243685: MammoScreen BD (2025), 0 descendants of its own

## Indications for use
WRDensity is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. WRDensity provides an ACR BI-RADS 5th Edition breast density category to aid interpreting physicians in the assessment of breast tissue composition. WRDensity produces adjunctive information. It is not a diagnostic aid.

Source page: https://510kreport.com/device/K202013
Methodology: https://510kreport.com/methodology