FDA 510(k) Application Details - K071972

Device Classification Name System, Image Processing, Radiological

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510(K) Number K071972
Device Name System, Image Processing, Radiological
Applicant AGFA HEALTHCARE CORP.
10 SOUTH ACADEMY ST.
GREENVILLE, SC 29601 US
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Contact TOM HOLBROOK
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 07/17/2007
Decision Date 07/30/2007
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 Y
Expedited Review



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