FDA 510(k) Application Details - K173588

Device Classification Name System, Image Processing, Radiological

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510(K) Number K173588
Device Name System, Image Processing, Radiological
Applicant Philips Medical Systems Technologies, Ltd.
PO Box 325
Building 34
Haifa 3100202 IL
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Contact Yoram Levy
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 11/20/2017
Decision Date 01/12/2018
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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