FDA 510(k) Application Details - K181177

Device Classification Name System, Image Processing, Radiological

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510(K) Number K181177
Device Name System, Image Processing, Radiological
Applicant Philips Medical Systems Nederland BV
Veenpluis 4-6
Best 5684PC NL
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Contact Chandrika Srinivasan
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 05/02/2018
Decision Date 05/31/2018
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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