510(k) · Cleared
ClearednordicAudio (1.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nordicneurolab AS · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Mar 20, 2026 as substantially equivalent to K232680 (Nordicneurolab AS, 2023) after a 269-day review. Its family tree reaches back 6 generations to 2005.
- Decided
- Mar 20, 2026
- Review
- 269 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K043290 (2005). No later device cites it as a predicate yet.
- Root · 6 generations backK043290 Mindstate Functional Data Acquisition Device, Version 1.0Neurognostics, Inc. · 2005
- 5 generations backK073099 Fmri Hardware SystemNordicneurolab · 2007
- 4 generations backK080515 Fmri Hardware SystemNordicneurolab · 2008 · Recalled
- 3 generations backK092253 Modification to Fmri Hardware SystemNordicneurolab · 2009 · Recalled
- 2 generations backK191032 fMRI Hardware SystemNordicneurolab AS · 2019
- 1 generation backK232680 fMRI Hardware SystemNordicneurolab AS · 2023
- This deviceK251937 nordicAudio (1.0)Nordicneurolab AS · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K043290 | Mindstate Functional Data Acquisition Device, Version 1.0 | Neurognostics, Inc. | 2005 | — |
| −5 | K073099 | Fmri Hardware System | Nordicneurolab | 2007 | — |
| −4 | K080515 | Fmri Hardware System | Nordicneurolab | 2008 | 1 |
| −3 | K092253 | Modification to Fmri Hardware System | Nordicneurolab | 2009 | 1 |
| −2 | K191032 | fMRI Hardware System | Nordicneurolab AS | 2019 | — |
| −1 | K232680 | fMRI Hardware System | Nordicneurolab AS | 2023 | — |
| 0 (this device) | K251937 | nordicAudio (1.0) | Nordicneurolab AS | 2026 | — |
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 |
|---|---|---|---|
| * | K232680 | fMRI Hardware SystemSummary page 5…stimuli and enable subject operator Device Description Summary 21 CFR 807.92(a)(4) IK232680 IIfMRI Hardware System (AudioSystem) I N Predicate #… | 2023 |
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 21 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 6 ancestors have 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. 2026, 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 nordicAudio allows auditory signals from a source in the control room to enter the Magnet room and to be presented to the subject. The system consists of headphones connected through an access point. From this unit the system is connected to an audio hub unit in the control room, through a fiber cable. Standard audio sources can be connected to the audio hub and by this bring the audio to the subject. The device is used to present audio to a subject…
Read the full statement (164 words)
The nordicAudio allows auditory signals from a source in the control room to enter the Magnet room and to be presented to the subject. The system consists of headphones connected through an access point. From this unit the system is connected to an audio hub unit in the control room, through a fiber cable. Standard audio sources can be connected to the audio hub and by this bring the audio to the subject.
The device is used to present audio to a subject during an MRI examination. It also facilitates communication between the operator and subject during the examination. The nordicAudio is intended to be used by trained professionals within the MRI environment.
nordicAudio is intended to be used by subjects and operated by trained professionals such as radiographers or technologist performing functional, clinical or interventional MRI scans. The Headset is designed for children above the age of 4 years.
The nordicAudio is intended to be used in functional, clinical or interventional MRI environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251937 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251937: nordicAudio (1.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251937
Report an extraction error
Are you the manufacturer?
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