FDA 510(k) Application Details - K160426

Device Classification Name System, Image Processing, Radiological

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510(K) Number K160426
Device Name System, Image Processing, Radiological
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
2501 NORTH BARRINGTON RD.
HOFFMAN ESTATES, IL 60192 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 02/16/2016
Decision Date 03/04/2016
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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