510(k) · Cleared

Cleared

Esteem 1.5T Mri System

K972826510(k) TraditionalCleared Oct 15, 199778-day reviewClass II21 CFR 892.1000

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Elscint Mr, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Oct 15, 1997 as substantially equivalent to K962677 (Elscint Mr, Inc., 1996) after a 78-day review. Its family tree reaches back 2 generations to 1994.

Decided: Oct 15, 1997
Review: 78 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K942953 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK942953 Oracle Mri Whole Body MR Imaging SystemOtsuka Electronics USA, Inc. · 1994
1 generation backK962677 Esteem 1.5T Mri SystemElscint Mr, Inc. · 1996
This deviceK972826 Esteem 1.5T Mri SystemElscint Mr, Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K942953	Oracle Mri Whole Body MR Imaging System	Otsuka Electronics USA, Inc.	1994	—
−1	K962677	Esteem 1.5T Mri System	Elscint Mr, Inc.	1996	—
0 (this device)	K972826	Esteem 1.5T Mri System	Elscint Mr, Inc.	1997	—

FIG. 1 — Lineage of K972826, 1994–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LNH device

#1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K962677	Esteem 1.5T Mri System Summary page 3 …ogical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure Elscint MR, Inc. Page 1 of 1 Elscint 510(k) number K962677 Device Name: Gyrex Esteem 1.5T MRI System Indications for Use: The Gyrex Esteem 1.5T MRI System is a general purpose whole-body…	Elscint Mr, Inc.	1996	—

Also cleared against K962677: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K962677.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNH

26in 2025

2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007high 140 (2015) · low 35 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LNH

8in 2025

2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007high 1,263 (2025) · low 84 (2021)2025

MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	12	35	25	114
2008	19	53	12	167
2009	17	70	7	194
2010	12	94	17	165
2011	16	81	11	182
2012	22	89	5	170
2013	19	108	2	107
2014	17	108	13	119
2015	19	140	12 (2)	113
2016	20	108	1	135
2017	18	98	0	121
2018	29	128	71	158
2019	26	62	5	158
2020	32	121	4	98
2021	27	87	41	84
2022	30	74	13	138
2023	30	124	10 (1)	159
2024	26	104	4	281
2025	26	122	8 (5)	1,263
2026	24	126	43	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K972826 · printed Nov 5, 2026

Cite this page

510(k) Report. “K972826: Esteem 1.5T Mri System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972826

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026