FDA 510(k) Application Details - K173611

Device Classification Name System, Image Processing, Radiological

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510(K) Number K173611
Device Name System, Image Processing, Radiological
Applicant Siemens Medical Solutions, USA Inc.
40 Liberty Boulevard
65-1A
Malvern, PA 19355 US
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Contact Patricia D. Jones
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 11/22/2017
Decision Date 03/16/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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