510(k) · Cleared
ClearedHeadphones, Patient Alert, Standalone Interface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neocoil, LLC · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jul 24, 2014 as substantially equivalent to K103507 (Medical Visors, Inc., 2011) after a 237-day review. Its family tree reaches back 3 generations to 1993. 2 later devices descend from it.
- Decided
- Jul 24, 2014
- Review
- 237 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K921891 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK921891 Silent ScanAvotec, Inc. · 1993
- 2 generations backK994351 M.R. Vision 2000 Ultra Audio Visual System / Commander X6 SystemResonance Technology, Inc. · 2000 · Recalled
- 1 generation backK103507 Medical Visors MV100Medical Visors, Inc. · 2011
- This deviceK133670 Headphones, Patient Alert, Standalone InterfaceNeocoil, LLC · 2014
- Descendant · cites it directly · 1 of its ownK173409 Wireless Audio SystemNeocoil, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK193218 Innovision AudioInnovere Medical, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921891 | Silent Scan | Avotec, Inc. | 1993 | — |
| −2 | K994351 | M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System | Resonance Technology, Inc. | 2000 | 2 |
| −1 | K103507 | Medical Visors MV100 | Medical Visors, Inc. | 2011 | — |
| 0 (this device) | K133670 | Headphones, Patient Alert, Standalone Interface | Neocoil, LLC | 2014 | — |
| +1 | K173409 | Wireless Audio System | Neocoil, LLC | 2018 | — |
| +2 | K193218 | Innovision Audio | Innovere Medical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K103507 | Medical Visors MV100Summary page 1…ones, a remote audio data source unit, patient alert, and communications infrastructure. 5.7. Predicate Device *Medical Visors MV1 00 (K1 03507), cleared on 02/08/2011 5.8. Comparison to Predicate The NeoCoil Patient Communication and Entertainment Sy… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173409 | Wireless Audio System | 2018 | 1 |
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 21 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K173409 (Neocoil, LLC, 2018) has gone furthest, with 1 descendant 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. 2014, 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?
The NeoCoil PCE system is intended to provide audio entertainment and facilitate patient communication in MRI environments at 3 tesla field strength and below
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133670 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133670: Headphones, Patient Alert, Standalone Interface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133670
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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