FDA 510(k) Application Details - K151850

Device Classification Name System, Image Processing, Radiological

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510(K) Number K151850
Device Name System, Image Processing, Radiological
Applicant MCKESSON ISRAEL LTD.
HAROKMIM 26
HOLON 5885849 IL
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Contact GILBERT WONG
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 07/07/2015
Decision Date 08/11/2015
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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