# K211356: GIQuant

- Pathway: 510(k) (Traditional)
- Applicant: Motilent, Ltd.
- Decided: Nov 8, 2021 after 189 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: 12 generations back to K911667 (1991). 49 ancestors in all.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123302: IB Clinic, Imaging Biometrics, LLC (2013) Summary page 4.

## Indications for use
GIQuant is a post-processing software integrated into existing medical imaging workflows that is intended to derive motion related parameters from abdominal data obtained during magnetic resonance imaging (MRI). GIQuant is designed to aid trained physicians in advanced image assessment, treatment consideration, and monitoring of therapeutic response. The information provided by GIQuant should not be used in isolation when making patient management decisions.

Source page: https://510kreport.com/device/K211356
Methodology: https://510kreport.com/methodology