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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
510(k) Number K200213
Device Name Biograph mMR with syngo MR E11P-AP01 system software
Applicant
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd.
Mail Code 65-1a
Malvern,  PA  19355
Applicant Contact Cordell L. Fields
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd.
Mail Code 65-1a
Malvern,  PA  19355
Correspondent Contact Cordell L. Fields
Regulation Number892.1200
Classification Product Code
OUO  
Subsequent Product Codes
KPS   LNH   LNI  
Date Received01/28/2020
Decision Date 05/11/2020
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
Recalls CDRH Recalls
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