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510(k) Data Aggregation
K Number
K103507Device Name
MEDICAL VISORS MV100
Manufacturer
MEDICAL VISORS, INC
Date Cleared
2011-02-08
(71 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL VISORS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
Medical Visors MV100 is a self-contained video and audio entertainment system to be worn by patients during an MRI procedure. A patient wears a system comprised of video glasses and headphones unit on their head and holds a controller in their hand.
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