# K143368: GenIQ

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Jul 29, 2015 after 246 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: 9 generations back to K896095 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130278: MR Permeability, Philips Medical Systems Nederland B.V. (2013) Summary page 6.

## Indications for use
GenIQ is an automated post-processing software option that is indicated for use on dynamic magnetic resonance imaging data sets to generate parametric images from the image intensity variations over time. This dynamic change in signal intensity is used to calculate functional parameters related to tissue flow and leakage of the contrast agent from the intravascular to the extracellular space. GenIQ provides information that when interpreted by a trained physician, can be useful for assessing tissue vascular properties.

Source page: https://510kreport.com/device/K143368
Methodology: https://510kreport.com/methodology