# K994117: MR Enhancer

- Pathway: 510(k) (Traditional)
- Applicant: I.Z.I. Corp.
- Decided: Feb 4, 2000 after 60 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
MR Enhancer is designed for use as a MRI accessory to improve image homogeneity by reducing skin-air interfaces, thereby improving images from such pulsing parameters as chemical shift fat saturation and gradient echo. MR Enhancer also serves as a stabilizing device to reduce vascular and tissue pulsation artifacts.

Source page: https://510kreport.com/device/K994117
Methodology: https://510kreport.com/methodology