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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 K073425
Device Name MODIFICATION TO AURORA MRI SYSTEM
Applicant
AURORA IMAGING TECHNOLOGY, INC.
39 HIGH ST.
NORTH ANDOVER,  MA  01845
Applicant Contact MICHAEL A DOUGLAS
Correspondent
AURORA IMAGING TECHNOLOGY, INC.
39 HIGH ST.
NORTH ANDOVER,  MA  01845
Correspondent Contact MICHAEL A DOUGLAS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/03/2007
Decision Date 09/16/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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