# K210415: QSM software, QSMetric

- Pathway: 510(k) (Traditional)
- Applicant: Medimagemetric, LLC
- Decided: Jul 22, 2021 after 161 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- 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 K971684 (1997). 32 ancestors in all.
No later device cites it as a predicate yet.
9 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131241: SWIP, Philips Medical Systems Nederland B.V. (2013) Summary page 4.

## Indications for use
QSM software (QSMetric™) is intended for use in the post-acquisition image enhancement of 3D MR images of the brain acquired using a gradient-echo sequence at 1.5T, 3T and 7T field strengths. QSM uses phase information to enhance contrast between tissues presenting magnetic susceptibility differences, such as deoxygenated blood, iron or calcium deposits. When used in combination with other clinical information, QSM may aid the qualified physicians in visualizing tissue structures with magnetic susceptibility contrasts and measuring their susceptibility values.

Source page: https://510kreport.com/device/K210415
Methodology: https://510kreport.com/methodology