# K972592: 2T Prestige (100-6321-0107)/Privilege (100-6326-0102)/Gyrex V-EP (100-6327-0101)

- Pathway: 510(k) (Traditional)
- Applicant: Elscint, Inc.
- Decided: Sep 15, 1997 after 66 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- 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.
- K944331: Model 528GE Series, Medical Advances, Inc. (1995) Summary page 1.

## Indications for use
Magnetic Resonance Imaging of small extremity joints.

Source page: https://510kreport.com/device/K972592
Methodology: https://510kreport.com/methodology