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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 K130692
Device Name M2 WRIST 2 MRI SYSTEM
Applicant
Aspect Imaging , Ltd.
291 Hillside Ave.
Somerset,  MA  02726
Applicant Contact George Hattub
Correspondent
Aspect Imaging , Ltd.
291 Hillside Ave.
Somerset,  MA  02726
Correspondent Contact George Hattub
Regulation Number892.1000
Classification Product Code
LNH  
Date Received03/13/2013
Decision Date 01/14/2014
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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