# K180125: PowerLook Density Assessment Software

- Pathway: 510(k) (Traditional)
- Applicant: Icad, Inc.
- Decided: Apr 5, 2018 after 79 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: 9 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)
- K132742: M-VU Breast Density, Vucomp, Inc. (2013) Summary page 5.
- K152028: Volpara Imaging Software, Matakina Technologies Limited (2015) Summary page 5.

## Most influential descendants
- K211506: PowerLook Density Assessment V4.0 (2021), 0 descendants of its own
- K201411: Visage Breast Density (2021), 0 descendants of its own

## Indications for use
PowerLook Density Assessment is a software application intended for use with digital breast tomosynthesis synthesized 2D images from tomosynthesis exams. PowerLook Density Assessment provides an ACR BI-RADS Atlas 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. PowerLook Density Assessment produces adjunctive information. It is not a diagnostic aid.

Source page: https://510kreport.com/device/K180125
Methodology: https://510kreport.com/methodology