# K962677: Esteem 1.5T Mri System

- Pathway: 510(k) (Traditional)
- Applicant: Elscint Mr, Inc.
- Decided: Sep 20, 1996 after 73 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 K942953 (1994). 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)
- K942953: Oracle Mri Whole Body MR Imaging System, Otsuka Electronics USA, Inc. (1994) Summary page 1.

## Most influential descendants
- K972826: Esteem 1.5T Mri System (1997), 0 descendants of its own
- K972340: Insight 7000 Phased Array Torso Coil (1997), 0 descendants of its own

## Indications for use
The Elscint Esteem 1.5T MRI system is designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density, NMR relaxation time (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning.

Source page: https://510kreport.com/device/K962677
Methodology: https://510kreport.com/methodology