# K192973: densitas densityai

- Pathway: 510(k) (Special)
- Applicant: Densitas, Inc.
- Decided: Feb 19, 2020 after 118 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.
5 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170540: DM-Density, Densitas, Inc. (2018) Summary page 4.

## Most influential descendants
- K202013: WRDensity by Whiterabbit.ai (2020), 2 descendants of its own
- K241561: MammoScreen BD (2024), 1 descendant of its own
- K222275: Saige-Density (2022), 1 descendant of its own
- K243685: MammoScreen BD (2025), 0 descendants of its own
- K243705: Saige-Density (2.5.0) (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K192973
Methodology: https://510kreport.com/methodology