# K142037: Quantra

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Oct 10, 2014 after 74 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). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120472: Quantra, Hologic, Inc. (2012) Summary page 4.

## Most influential descendants
- K163623: Quantra (2017), 0 descendants of its own

## Indications for use
Quantra™ is a software application intended for use with images acquired using digital breast x-ray systems. Quantra calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Quantra also provides area breast density as a ratio of fibroglandular tissue area and total breast area estimates. Quantra segregates breast density into categories, which may be useful in the reporting of consistent BI-RADS® breast composition categories as mandated by certain state regulations. The Quantra results for each image, breast, and subject, are intended to aid radiologists in the assessment of breast tissue composition. Quantra produces adjunctive information; it is not an interpretive or diagnostic aid.

Source page: https://510kreport.com/device/K142037
Methodology: https://510kreport.com/methodology