# K965044: Gyrex 2T Prestige Model NO. 100-6321-0107 and Gyrex Privilege Model NO. 100-6326-0102

- Pathway: 510(k) (Traditional)
- Applicant: Elscint, Inc.
- Decided: Jun 16, 1997 after 185 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
Whole Body Magnet Resonance Imaging

Source page: https://510kreport.com/device/K965044
Methodology: https://510kreport.com/methodology