FDA 510(k) Application Details - K140909

Device Classification Name System, Image Processing, Radiological

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510(K) Number K140909
Device Name System, Image Processing, Radiological
Applicant MCKESSON MEDICAL IMAGING COMPANY
5995 WINWARD PARKWAY
ALPHARETTA, GA 30005 US
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Contact PAUL SUMNER
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 04/09/2014
Decision Date 07/02/2014
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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