# K945791: Gyres 2T Prestige

- Pathway: 510(k) (Traditional)
- Applicant: Elscint, Inc.
- Decided: Sep 19, 1995 after 298 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.
5 later devices descend from it; 5 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K980306: Gyrex 2T Prestige, Gyrex Prima Itg, Gyrex Privilege, Gyrex V-EP (1998), 0 descendants of its own
- K974614: Gyrex 2T Prestige 100-6321-0107, Gyrex Priviledge 100-6326-0102, Gyrex Prima 1TG 100-6250-0102 (1998), 0 descendants of its own
- K972592: 2T Prestige (100-6321-0107)/Privilege (100-6326-0102)/Gyrex V-EP (100-6327-0101) (1997), 0 descendants of its own
- K965044: Gyrex 2T Prestige Model NO. 100-6321-0107 and Gyrex Privilege Model NO. 100-6326-0102 (1997), 0 descendants of its own
- K970005: Gyrex 2T-Prestige (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K945791
Methodology: https://510kreport.com/methodology