# K103507: Medical Visors MV100

- Pathway: 510(k) (Traditional)
- Applicant: Medical Visors, Inc.
- Decided: Feb 8, 2011 after 71 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: 2 generations back to K921891 (1993). 2 ancestors in all.
3 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)
- K994351: M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System, Resonance Technology, Inc. (2000) Summary page 1.

## Most influential descendants
- 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

## Indications for use
Medical Visors MV100 is intended for use in an MRI environment to provide audio-visual entertainment in order to improve patient comfort and calm patients. The Medical Visors MV100 have been shown to be "MR Conditional" for field strengths up to (and including) 3T and with the MR system operating in the Normal Operating Mode (average WB SAR <2W/kg) only. Medical Visor MV100 is not recommended for diagnostic exams of the eyes, eye canal, ear, ear canal and nose. The user is instructed to keep the control unit outside of the imaging field of view. The patient must be given the standard ear plug hearing protection for the MRI used. The MV100 is not a hearing protection device. The MV100 should not be used if the MR noise level with ear plug protection is within 6dB of noise limit. The MV100 should not be used if the technician has critical communication with the patient, such as a lung scan.

Source page: https://510kreport.com/device/K103507
Methodology: https://510kreport.com/methodology