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U.S. Department of Health and Human Services

510(k) Premarket Notification

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ProductCode: KPS Applicant: SIEMENS MEDICAL SOLUTIONS USA, INC. Decision Date To: 05/21/2022
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scenium SIEMENS MEDICAL SOLUTIONS USA, INC. K123528 12/20/2012
scenium 2.0 SIEMENS MEDICAL SOLUTIONS USA, INC. K121074 06/08/2012
scenium SIEMENS MEDICAL SOLUTIONS USA, INC. K133654 02/28/2014
symbia SIEMENS MEDICAL SOLUTIONS USA, INC. K131634 08/16/2013
biograph true pet/ct family software SIEMENS MEDICAL SOLUTIONS USA, INC. K141971 09/12/2014
symbia 6.0 SIEMENS MEDICAL SOLUTIONS USA, INC. K142006 08/21/2014
biograph horizon pet/ct SIEMENS MEDICAL SOLUTIONS USA, INC. K152880 01/12/2016
biograph mct and mct flow pet/ct scanners Siemens Medical Solutions USA, Inc. K151486 07/17/2015
biograph horizon pet/ct and biograph mct pet/ct and biograph mct flow pet/ct Siemens Medical Solutions USA, Inc. K162736 10/25/2016
biograph mmr with syngo mr e11p system software Siemens Medical Solutions USA, Inc. K163234 02/28/2017
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