510(k) · Cleared
ClearedInnovision Audio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovere Medical, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Apr 7, 2020 as substantially equivalent to K173409 (Neocoil, LLC, 2018) after a 138-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Apr 7, 2020
- Review
- 138 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K921891 (1993). No later device cites it as a predicate yet.
- Root · 5 generations backK921891 Silent ScanAvotec, Inc. · 1993
- 4 generations backK994351 M.R. Vision 2000 Ultra Audio Visual System / Commander X6 SystemResonance Technology, Inc. · 2000 · Recalled
- 3 generations backK103507 Medical Visors MV100Medical Visors, Inc. · 2011
- 2 generations backK133670 Headphones, Patient Alert, Standalone InterfaceNeocoil, LLC · 2014
- 1 generation backK173409 Wireless Audio SystemNeocoil, LLC · 2018
- This deviceK193218 Innovision AudioInnovere Medical, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921891 | Silent Scan | Avotec, Inc. | 1993 | — |
| −4 | K994351 | M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System | Resonance Technology, Inc. | 2000 | 2 |
| −3 | K103507 | Medical Visors MV100 | Medical Visors, Inc. | 2011 | — |
| −2 | K133670 | Headphones, Patient Alert, Standalone Interface | Neocoil, LLC | 2014 | — |
| −1 | K173409 | Wireless Audio System | Neocoil, LLC | 2018 | — |
| 0 (this device) | K193218 | Innovision Audio | Innovere Medical, Inc. | 2020 | — |
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 |
|---|---|---|---|
| * | K173409 | Wireless Audio SystemSummary page 5…510(k) Number Device Name Manufacturer Primary Device K173409 Wireless Audio System NeoCoil, LLC 5.7 Comparison of Technological Characteristi… | 2018 |
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 27 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
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. 2020, 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 Innovision Audio system is intended to provide entertainment and facilitate communication from the operator to the patient in the MRI scanner environment. The system is intended for "MR Conditional" use during supine MRI examinations at 1.5T and 3.0T.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193218: Innovision Audio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193218
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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