FDA 510(k) Application Details - K173897

Device Classification Name System, Image Processing, Radiological

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510(K) Number K173897
Device Name System, Image Processing, Radiological
Applicant Siemens Medical Solutions USA, Inc.
810 Innovation Drive
Knoxville, TN 37932 US
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Contact Veronica Padharia
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 12/22/2017
Decision Date 04/05/2018
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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