# K974614: Gyrex 2T Prestige 100-6321-0107, Gyrex Priviledge 100-6326-0102, Gyrex Prima 1TG 100-6250-0102

- Pathway: 510(k) (Traditional)
- Applicant: Elscint, Inc.
- Decided: Mar 4, 1998 after 83 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: 1 generation back to K945791 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945791: Gyres 2T Prestige, Elscint, Inc. (1995) Summary page 1.
- K954039: Gyrex Privilege, Elscint, Inc. (1995) Summary page 1.
- K970990: Gyrex Prima 1TG 1.0T Mri System, Elscint Mr, Inc. (1997) Summary page 1.

## Indications for use
The production of a series of images of the heart at different phases of the cardiac cycle.

Source page: https://510kreport.com/device/K974614
Methodology: https://510kreport.com/methodology