# K191959: QuantX Breast MRI Biopsy Guidance Plugin

- Pathway: 510(k) (Traditional)
- Applicant: Qlarity Imaging
- Decided: Nov 8, 2019 after 108 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 K954678 (1996). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041286: Dynacad V1.0, Mri Devices Corp. (2004) Summary page 4.

## Indications for use
The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI guided interventional procedures.

Source page: https://510kreport.com/device/K191959
Methodology: https://510kreport.com/methodology