# K980306: Gyrex 2T Prestige, Gyrex Prima Itg, Gyrex Privilege, Gyrex V-EP

- Pathway: 510(k) (Traditional)
- Applicant: Elscint, Inc.
- Decided: Apr 2, 1998 after 65 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: 2 generations back to K954039 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K962618: Gyrex V-EP, Elscint, Inc. (1996) Summary page 1.
- K970990: Gyrex Prima 1TG 1.0T Mri System, Elscint Mr, Inc. (1997) Summary page 1.

## Indications for use
HOLE BODY MAGHETIC RESQNANCE IMAGIHE

Source page: https://510kreport.com/device/K980306
Methodology: https://510kreport.com/methodology