# K133670: Headphones, Patient Alert, Standalone Interface

- Pathway: 510(k) (Abbreviated)
- Applicant: Neocoil, LLC
- Decided: Jul 24, 2014 after 237 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: 3 generations back to K921891 (1993). 3 ancestors in all.
2 later devices descend 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)
- K103507: Medical Visors MV100, Medical Visors, Inc. (2011) Summary page 1.

## Most influential descendants
- K173409: Wireless Audio System (2018), 1 descendant of its own
- K193218: Innovision Audio (2020), 0 descendants of its own

## Indications for use
The NeoCoil PCE system is intended to provide audio entertainment and facilitate patient communication in MRI environments at 3 tesla field strength and below

Source page: https://510kreport.com/device/K133670
Methodology: https://510kreport.com/methodology