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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 K121434
Device Name SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO
Applicant
SIEMENS MEDICAL SOLUTIONS, INC.
51 VALLEY STREAM PARKWAY
MAIL CODE D02
MALVERN,  PA  19355
Applicant Contact MICHELLE L BYRNE
Correspondent
SIEMENS MEDICAL SOLUTIONS, INC.
51 VALLEY STREAM PARKWAY
MAIL CODE D02
MALVERN,  PA  19355
Correspondent Contact MICHELLE L BYRNE
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received05/14/2012
Decision Date 11/05/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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