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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K103507
Device Name MEDICAL VISORS MV100
Applicant
Medical Visors, Inc.
3834 Orchid Ln.
Suite B
Calabasas,  CA  91302
Applicant Contact BRAIN HUGHES
Correspondent
Medical Visors, Inc.
3834 Orchid Ln.
Suite B
Calabasas,  CA  91302
Correspondent Contact BRAIN HUGHES
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/29/2010
Decision Date 02/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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