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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 Boulevard Mailcode 65-1A
Malvern,  PA  19355
Applicant Contact Cordell L. Fields
Correspondent
Siemens Medical Solutions, USA, Inc.
40 Liberty Boulevard Mailcode 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
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