# K193218: Innovision Audio

- Pathway: 510(k) (Traditional)
- Applicant: Innovere Medical, Inc.
- Decided: Apr 7, 2020 after 138 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: 5 generations back to K921891 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173409: Wireless Audio System, Neocoil, LLC (2018) Summary page 5.

## Indications for use
The Innovision Audio system is intended to provide entertainment and facilitate communication from the operator to the patient in the MRI scanner environment. The system is intended for "MR Conditional" use during supine MRI examinations at 1.5T and 3.0T.

Source page: https://510kreport.com/device/K193218
Methodology: https://510kreport.com/methodology