# K120472: Quantra

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Jun 22, 2012 after 127 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: 8 generations back to K904519 (1991). 20 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082483: Quantra, Hologic, Inc. (2008) Summary page 1.
- K050196: Sectra IDS5 Workstation, Sectra Imtec AB (2005) Summary page 1.
- K102556: Volpara, Version 1.3, Matakina Technology Limited (2010) Summary page 1.

## Most influential descendants
- K142037: Quantra (2014), 1 descendant of its own
- K163623: Quantra (2017), 0 descendants of its own
- K130704: Microdose SI (2013), 0 descendants of its own

## Indications for use
Quantra Tm 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; and area breast density as a ratio of fibroglandular tissue area and total breast area estimates. It segregates breast density into BL1-RADS-Iike breast composition categories, which may be useful in the reporting of consistent breast composition values as mandated by certain state regulations. Quantra provides these numerical values for each image, breast, and subject, to aid radiologists in the assessment of breast tissue composition. Quantra produces adjunctive information; it is not an interpretive or diagnostic aid. Quantra runs on a Windows platform.

Source page: https://510kreport.com/device/K120472
Methodology: https://510kreport.com/methodology