510(k) · Cleared
ClearedSilent Scan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avotec, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on May 13, 1993 after a 386-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- May 13, 1993
- Review
- 386 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK921891 Silent ScanAvotec, Inc. · 1993
- Descendant · cites it directly · 4 of its ownK994351 M.R. Vision 2000 Ultra Audio Visual System / Commander X6 SystemResonance Technology, Inc. · 2000 · Recalled
- Descendant · 2 generations on · 3 of its ownK103507 Medical Visors MV100Medical Visors, Inc. · 2011
- Descendant · 3 generations on · 2 of its ownK133670 Headphones, Patient Alert, Standalone InterfaceNeocoil, LLC · 2014
- Descendant · 4 generations on · 1 of its ownK173409 Wireless Audio SystemNeocoil, LLC · 2018
- Descendant · 5 generations on · 0 of its ownK193218 Innovision AudioInnovere Medical, Inc. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K994351M.R. Vision 2000 Ultra Audio Visual System / Commander X6 SystemResonance Technology, Inc. · 2000 · cites it directly4descendants
- K103507Medical Visors MV100Medical Visors, Inc. · 2011 · 2 generations on3descendants
- K133670Headphones, Patient Alert, Standalone InterfaceNeocoil, LLC · 2014 · 3 generations on2descendants
- K173409Wireless Audio SystemNeocoil, LLC · 2018 · 4 generations on1descendant
- K193218Innovision AudioInnovere Medical, Inc. · 2020 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K921891 | Silent Scan | Avotec, Inc. | 1993 | — |
| +1 | K994351 | M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System | Resonance Technology, Inc. | 2000 | 2 |
| +2 | K103507 | Medical Visors MV100 | Medical Visors, Inc. | 2011 | — |
| +3 | K133670 | Headphones, Patient Alert, Standalone Interface | Neocoil, LLC | 2014 | — |
| +4 | K173409 | Wireless Audio System | Neocoil, LLC | 2018 | — |
| +5 | K193218 | Innovision Audio | Innovere Medical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K994351 (Resonance Technology, Inc., 2000) has gone furthest, with 4 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.
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 | — |
https://510kreport.com/device/K921891 · printed Nov 4, 2026
Cite this page
510(k) Report. “K921891: Silent Scan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K921891
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026