# K970990: Gyrex Prima 1TG 1.0T Mri System

- Pathway: 510(k) (Traditional)
- Applicant: Elscint Mr, Inc.
- Decided: Aug 25, 1997 after 160 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.
53 later devices descend from it; 3 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Prestige 2.0T MRI System: named in the summary without a submission number

## Most influential descendants
- K981358: Artoscan S (1998), 50 descendants of its own
- K990968: E-SCAN (1999), 49 descendants of its own
- K020164: E-Scan XQ (2002), 48 descendants of its own
- K032121: Modification to E-Scan XQ (2003), 47 descendants of its own
- K042236: G-SCAN (2004), 45 descendants of its own

## Indications for use
The Gyrex Prima 1TG 1.0T MRI system is a general purpose whole-body MRI system that produces images of the internal structures of the head, body, or extremities. The indications for use are not dissimilar to established indications for use for other general purpose whole-body MRI systems. The established indications for use are that when interpreted by a trained physician, MRI can be useful in determination of a diagnosis, surgery planning, or therapy planning and is used in a clinic or hospital setting.

Source page: https://510kreport.com/device/K970990
Methodology: https://510kreport.com/methodology