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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 K070629
Device Name FLEX AND LOOP COIL SET 1.5 T
Applicant
Siemens Medical Solutions
Henkestrasse 127
Erlangen,  DE D91052
Applicant Contact HELMUT NEUMANN
Correspondent
Tuv Sud America, Inc.
1775 Old Hwy. 8 NW
New Brighton,  MN  55112
Correspondent Contact STEFAN PREISS
Regulation Number892.1000
Classification Product Code
MOS  
Date Received03/07/2007
Decision Date 03/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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