| K-number | K251937 |
| Device name | nordicAudio (1.0) |
| Applicant | Nordicneurolab AS |
| Product code | LNH |
| Device class | Class II |
| Decision date | Mar 20, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 892.1000 |
The nordicAudio is an MR-conditional audio system designed to present auditory signals to subjects during MRI examinations while reducing acoustic noise and enabling communication between operators and subjects. It consists of an MR-compatible headset with optical data transmission, a battery unit, and an audio hub that interfaces with standard commercial audio sources via fiber cable.
The nordicAudio uses MEMS (Micro Electro Mechanical Systems) technology for its headset, whereas the predicate AudioSystem uses Electrostatic technology. Both devices deliver the same functional characteristics—transmitting auditory signals from the control room into the scanner room and presenting them to the patient.
Not stated in this summary.
The nordicAudio is substantially equivalent to the predicate device (AudioSystem, K232680) because it has the same intended use and similar basic technological characteristics for presenting audio during MRI scans. Although the underlying transducer technology differs (MEMS vs. Electrostatic), testing and verification data demonstrate equivalent safety and performance profiles, and the differences do not raise additional safety or effectiveness concerns.
View the full FDA submission: accessdata.fda.gov