510(k) · Cleared

Cleared

Echostar Comfort 1.5T Mri

K141945510(k) TraditionalCleared Feb 3, 2015201-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

Alltech Medical Systems America, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Feb 3, 2015 as substantially equivalent to K113511 (Alltech Medical Systems America, Inc., 2012) after a 201-day review. Its family tree reaches back 2 generations to 2008. 1 of the 4 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided: Feb 3, 2015
Review: 201 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K082100 (2008). 1 later device descends from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 2 generations backK082100 Alltech Echostar 1.5 T MR SystemAlltech Medical Systems America, Inc. · 2008
1 generation backK113511 Echostar Spica 1.5T MR SystemAlltech Medical Systems America, Inc. · 2012 · Recalled (Class I)
This deviceK141945 Echostar Comfort 1.5T MriAlltech Medical Systems America, Inc. · 2015
Descendant · cites it directly · 0 of its ownK163192 Comfort EC710Alltech Medical Systems America, Inc. · 2017

Class I recalls in this family

K113511 Echostar Spica 1.5T MR Systemdirect predicate · 2012

Most influential descendants

Showing 1 of 1 · See all

K163192Comfort EC710Alltech Medical Systems America, Inc. · 2017 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K082100	Alltech Echostar 1.5 T MR System	Alltech Medical Systems America, Inc.	2008	—
−1	K113511	Echostar Spica 1.5T MR System	Alltech Medical Systems America, Inc.	2012	Class I
0 (this device)	K141945	Echostar Comfort 1.5T Mri	Alltech Medical Systems America, Inc.	2015	—
+1	K163192	Comfort EC710	Alltech Medical Systems America, Inc.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0

FIG. 1 — Lineage of K141945, 2008–2017Source: 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.

1 device in this family has a Class I recall. 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
*	K113511	Echostar Spica 1.5T MR System Summary page 4 …equivalent through the 510(k) premarket notification process, the Echostar Spica 1.5T MR System. The Echostar Spica 1.5T MR system was cleared by the FDA on May 2, 2012 (K113511). 21 CFR 807.92 (a)(4) Device Description The Echostar Comfort 1.5T MRI System represents a modification to the previously clear…	Alltech Medical Systems America, Inc.	2012	Class I

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K163192	Comfort EC710	Alltech Medical Systems America, Inc.	2017	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K113511Echostar Spica 1.5T MR SystemAlltech Medical Systems America, Inc. · 2012 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 3.7 years on median.
1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
Of its descendants, K163192 (Alltech Medical Systems America, Inc., 2017) has gone furthest, with 0 descendants of its own.

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. 2015, this device’s year, is highlighted.

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 Echostar Comfort 1.5T MRI System is a whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Transverse, sagittal, coronal and oblique planes may be imaged. MRI images produced by the Echostar Comfort system reflect the spatial distribution for the density of hydrogen nuclei (protons) spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K141945 · printed Nov 4, 2026

Cite this page

510(k) Report. “K141945: Echostar Comfort 1.5T Mri.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K141945

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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