# K970005: Gyrex 2T-Prestige

- Pathway: 510(k) (Traditional)
- Applicant: Elscint, Inc.
- Decided: Mar 28, 1997 after 85 days
- Product code: LNI (System, Nuclear Magnetic Resonance Spectroscopic)
- 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 K930265 (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.
- K930265: Hydrogen Spectroscopy Option-Probe #M1040HS/HT, GE Medical Systems (1995) Summary page 1.

Source page: https://510kreport.com/device/K970005
Methodology: https://510kreport.com/methodology