FDA 510(k) Application Details - K211459

Device Classification Name

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510(K) Number K211459
Device Name syngo.via MI WorkFlows, Scenium, syngo MBF
Applicant Siemens Medical Solutions USA, Inc.
810 Innovation Drive
Knoxville, TN 37932 US
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Contact Clayton Ginn
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Regulation Number

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Classification Product Code QIH
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Date Received 05/11/2021
Decision Date 06/10/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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