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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 K100141
Device Name 14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA
Applicant
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Mavern,  PA  19355
Applicant Contact JUDITH CAMPBELL
Correspondent
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Mavern,  PA  19355
Correspondent Contact JUDITH CAMPBELL
Regulation Number892.1000
Classification Product Code
MOS  
Date Received01/19/2010
Decision Date 08/27/2010
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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