510(k) · Cleared
ClearedMedical Visors MV100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Visors, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Feb 8, 2011 as substantially equivalent to K994351 (Resonance Technology, Inc., 2000) after a 71-day review. Its family tree reaches back 2 generations to 1993. 3 later devices descend from it.
- Decided
- Feb 8, 2011
- Review
- 71 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K921891 (1993). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK921891 Silent ScanAvotec, Inc. · 1993
- 1 generation backK994351 M.R. Vision 2000 Ultra Audio Visual System / Commander X6 SystemResonance Technology, Inc. · 2000 · Recalled
- This deviceK103507 Medical Visors MV100Medical Visors, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK133670 Headphones, Patient Alert, Standalone InterfaceNeocoil, LLC · 2014
- Descendant · 2 generations on · 1 of its ownK173409 Wireless Audio SystemNeocoil, LLC · 2018
- Descendant · 3 generations on · 0 of its ownK193218 Innovision AudioInnovere Medical, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921891 | Silent Scan | Avotec, Inc. | 1993 | — |
| −1 | K994351 | M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System | Resonance Technology, Inc. | 2000 | 2 |
| 0 (this device) | K103507 | Medical Visors MV100 | Medical Visors, Inc. | 2011 | — |
| +1 | K133670 | Headphones, Patient Alert, Standalone Interface | Neocoil, LLC | 2014 | — |
| +2 | K173409 | Wireless Audio System | Neocoil, LLC | 2018 | — |
| +3 | K193218 | Innovision Audio | Innovere Medical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K994351 | M.R. Vision 2000 Ultra Audio Visual System / Commander X6 SystemSummary page 1…em: Nuclear Magnetic Resonance Imaging Regulatory: Class 11, CRF 892.1000 Product code: 90 LH N Predicate device: M.R. Vision 2000 Ultra, Resonance Technologies, Inc. K-994351 Device description: Medical Visors MV100 is a self-contained video and audio entertainment system to be worn by patients during… | 2000 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133670 | Headphones, Patient Alert, Standalone Interface | 2014 | 2 |
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 18 years and passes through 3 companies; a new generation was cleared every 10.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K133670 (Neocoil, LLC, 2014) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 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?
Medical Visors MV100 is intended for use in an MRI environment to provide audio-visual entertainment in order to improve patient comfort and calm patients. The Medical Visors MV100 have been shown to be "MR Conditional" for field strengths up to (and including) 3T and with the MR system operating in the Normal Operating Mode (average WB SAR <2W/kg) only. Medical Visor MV100 is not recommended for diagnostic exams of the eyes, eye canal, ear, ear canal…
Read the full statement (158 words)
Medical Visors MV100 is intended for use in an MRI environment to provide audio-visual entertainment in order to improve patient comfort and calm patients.
The Medical Visors MV100 have been shown to be "MR Conditional" for field strengths up to (and including) 3T and with the MR system operating in the Normal Operating Mode (average WB SAR <2W/kg) only.
Medical Visor MV100 is not recommended for diagnostic exams of the eyes, eye canal, ear, ear canal and nose. The user is instructed to keep the control unit outside of the imaging field of view.
The patient must be given the standard ear plug hearing protection for the MRI used. The MV100 is not a hearing protection device. The MV100 should not be used if the MR noise level with ear plug protection is within 6dB of noise limit. The MV100 should not be used if the technician has critical communication with the patient, such as a lung scan.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103507: Medical Visors MV100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103507
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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