# K972826: Esteem 1.5T Mri System

- Pathway: 510(k) (Traditional)
- Applicant: Elscint Mr, Inc.
- Decided: Oct 15, 1997 after 78 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: 2 generations back to K942953 (1994). 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)
- K962677: Esteem 1.5T Mri System, Elscint Mr, Inc. (1996) Summary page 3.

## Indications for use
The Gyrex Esteem 1.5T 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. The SW Version 5.0 upgrade does not change or contain any additional indications for use.

Source page: https://510kreport.com/device/K972826
Methodology: https://510kreport.com/methodology