# K082483: Quantra

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Sep 12, 2008 after 15 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: 6 generations back to K904519 (1991). 18 ancestors in all.
25 later devices descend from it; 3 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050196: Sectra IDS5 Workstation, Sectra Imtec AB (2005) Summary page 1.
- K073272: Workstationone Breast Imaging Workstation, Three Palm Software, LLC (2007) Summary page 1.

## Most influential descendants
- K102556: Volpara, Version 1.3 (2010), 24 descendants of its own
- K132742: M-VU Breast Density (2013), 11 descendants of its own
- K152028: Volpara Imaging Software (2015), 8 descendants of its own
- K170540: DM-Density (2018), 7 descendants of its own
- K192973: densitas densityai (2020), 5 descendants of its own

## Indications for use
QuantraTM is a software application intended for use with Hologic digital mammography systems. Quantra calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Quantra provides these numerical values for each breast to aid radiologists in the assessment of breast tissue composition. Quantra produces adjunctive information; it is not an interpretive or diagnostic aid. Quantra is a software application which runs on the Hologic Cenova DICOM server (Class I exempt per 21 CFR § 892.2010 and 21 CFR § 892.2020).

Source page: https://510kreport.com/device/K082483
Methodology: https://510kreport.com/methodology