# K173409: Wireless Audio System

- Pathway: 510(k) (Traditional)
- Applicant: Neocoil, LLC
- Decided: Feb 16, 2018 after 107 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: 4 generations back to K921891 (1993). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133670: Headphones, Patient Alert, Standalone Interface, Neocoil, LLC (2014) Summary page 4.

## Most influential descendants
- K193218: Innovision Audio (2020), 0 descendants of its own

## Indications for use
The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate patient communication in MRI environments at 3 Tesla field strength and below.

Source page: https://510kreport.com/device/K173409
Methodology: https://510kreport.com/methodology