FDA 510(k) Application Details - K012072

Device Classification Name System, Image Processing, Radiological

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510(K) Number K012072
Device Name System, Image Processing, Radiological
Applicant VOXAR LIMITED
BONNINGTON BOND, 2 ANDERSON PL
EDINBURGH EH6 5NP GB
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Contact CONRAD CHIN
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 07/02/2001
Decision Date 07/12/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party Y
Expedited Review



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