# K994351: M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System

- Pathway: 510(k) (Traditional)
- Applicant: Resonance Technology, Inc.
- Decided: Mar 22, 2000 after 90 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K921891 (1993). 1 ancestor in all.
4 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)
- K921891: Silent Scan, Avotec, Inc. (1993) Summary page 1.

## Most influential descendants
- K103507: Medical Visors MV100 (2011), 3 descendants of its own
- K133670: Headphones, Patient Alert, Standalone Interface (2014), 2 descendants of its own
- K173409: Wireless Audio System (2018), 1 descendant of its own
- K193218: Innovision Audio (2020), 0 descendants of its own

## Recalls of this device
- May 14, 2007 · Not classified · Z-1824-2008: Potential safety concerns - Use of this product with a MRI may result in the headset's cord overheating and patients experiencing burns to the skin.
- May 14, 2007 · Not classified · Z-1823-2008: Potential safety concerns - Use of this product with a MRI may result in the headset's cord overheating and patients experiencing burns to the skin.

## Indications for use
The M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System is indicated for use as an accessory to the MRI environment to provide audio and visual to patients and thus improve patient comfort and aid in eliminating fear associated with MRI use.

Source page: https://510kreport.com/device/K994351
Methodology: https://510kreport.com/methodology