# K193102: MRIaudio PREM System with MRIview

- Pathway: 510(k) (Traditional)
- Applicant: Mriaudio, Inc.
- Decided: Jan 6, 2020 after 59 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
Longest line of descent: 1 generation back to K180100 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180100: MRIaudio PREM System, Mriaudio (2018) Summary page 4.

## Indications for use
The MRIaudio PREM System with MRIview is intended to provide audio and visual entertainment to patients 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/K193102
Methodology: https://510kreport.com/methodology