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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name coil, magnetic resonance, specialty
510(K) Number K113280
Device Name CAROTID COIL GE 1.5T
Applicant
TURSIOP TECHNOLOGIES LLC
11000 cedar ave., suite 280
cleveland,  OH  44106
Contact raju viswanthan
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/07/2011
Decision Date 11/23/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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