# K180100: MRIaudio PREM System

- Pathway: 510(k) (Traditional)
- Applicant: Mriaudio
- Decided: Jun 14, 2018 after 149 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K133670: Headphones, Patient Alert, Standalone Interface, Neocoil, LLC (2014). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K193102: MRIaudio PREM System with MRIview (2020), 0 descendants of its own

## Indications for use
The MRIaudio PREM system is intended to provide audio entertainment and facilitate patient communication in MRI environments, up to, and including, 3.0 Tesla. The product is not intended for medical diagnosis or treatment. Technologist control units are intended to be used outside of the MRI scan room.

Source page: https://510kreport.com/device/K180100
Methodology: https://510kreport.com/methodology