510(k) · Cleared

Recalled · 2007

M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System

K994351510(k) TraditionalCleared Mar 22, 200090-day reviewClass II21 CFR 892.1000Recalls 2

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

Resonance Technology, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Mar 22, 2000 as substantially equivalent to K921891 (Avotec, Inc., 1993) after a 90-day review. Its family tree reaches back 1 generation to 1993. 4 later devices descend from it. It has been recalled 2 times.

Decided: Mar 22, 2000
Review: 90 days
Class: Class II
Product code: LNH
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K921891 (1993). 4 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK921891 Silent ScanAvotec, Inc. · 1993
This deviceK994351 M.R. Vision 2000 Ultra Audio Visual System / Commander X6 SystemResonance Technology, Inc. · 2000
Descendant · cites it directly · 3 of its ownK103507 Medical Visors MV100Medical Visors, Inc. · 2011
Descendant · 2 generations on · 2 of its ownK133670 Headphones, Patient Alert, Standalone InterfaceNeocoil, LLC · 2014
Descendant · 3 generations on · 1 of its ownK173409 Wireless Audio SystemNeocoil, LLC · 2018
Descendant · 4 generations on · 0 of its ownK193218 Innovision AudioInnovere Medical, Inc. · 2020

Most influential descendants

Showing 4 of 4 · See all

K103507Medical Visors MV100Medical Visors, Inc. · 2011 · cites it directly3descendants
K133670Headphones, Patient Alert, Standalone InterfaceNeocoil, LLC · 2014 · 2 generations on2descendants
K173409Wireless Audio SystemNeocoil, LLC · 2018 · 3 generations on1descendant
K193218Innovision AudioInnovere Medical, Inc. · 2020 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K921891	Silent Scan	Avotec, Inc.	1993	—
0 (this device)	K994351	M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System	Resonance Technology, Inc.	2000	—
+1	K103507	Medical Visors MV100	Medical Visors, Inc.	2011	—
+2	K133670	Headphones, Patient Alert, Standalone Interface	Neocoil, LLC	2014	—
+3	K173409	Wireless Audio System	Neocoil, LLC	2018	—
+4	K193218	Innovision Audio	Innovere Medical, Inc.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2014	1	0
2018	1	0
2020	1	0

FIG. 1 — Lineage of K994351, 1993–2020Source: 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
*	K921891	Silent Scan Summary page 1 …(818) 882-5524 - Fax December 12, 1999 M.R.Vision 2000 Ultra Accessory to MRI System, Nuclear Magnetic Resonance Imaging Product Code: LNH Avocet Silent Scan K number K921891 The system consists of a pair of glasses coupled with an audio transducer and noise canceling headset. The headset decreases gra…	Avotec, Inc.	1993	—

Also cleared against K921891: 1 other device →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K103507	Medical Visors MV100	Medical Visors, Inc.	2011	3

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 14, 2007	Not classified	Z-1824-2008	Device Design	Potential safety concerns - Use of this product with a MRI may result in the headset's cord overheating and patients experiencing burns to the skin.
May 14, 2007	Not classified	Z-1823-2008	Device Design	Potential safety concerns - Use of this product with a MRI may result in the headset's cord overheating and patients experiencing burns to the skin.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K103507 (Medical Visors, Inc., 2011) has gone furthest, with 3 descendants of its own.
1 other device also cites its predicate K921891.

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 M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System is indicated for use as an accessory to the MRI environment to provide audio and visual to patients and thus improve patient comfort and aid in eliminating fear associated with MRI 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/K994351 · printed Nov 4, 2026

Cite this page

510(k) Report. “K994351: M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994351

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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