# K962618: Gyrex V-EP

- Pathway: 510(k) (Traditional)
- Applicant: Elscint, Inc.
- Decided: Sep 4, 1996 after 63 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 K954039 (1995). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954039: Gyrex Privilege, Elscint, Inc. (1995) Summary page 1.

## Most influential descendants
- K980306: Gyrex 2T Prestige, Gyrex Prima Itg, Gyrex Privilege, Gyrex V-EP (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

Source page: https://510kreport.com/device/K962618
Methodology: https://510kreport.com/methodology