FDA 510(k) Application Details - K130636

Device Classification Name Digitizer, Image, Radiological

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510(K) Number K130636
Device Name Digitizer, Image, Radiological
Applicant VIDAR SYSTEMS CORP.
365 Herndon Pkwy
HERNDON, VA 20170 US
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Contact CARRIE L BRANCART
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Regulation Number 892.2030

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Classification Product Code LMA
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Date Received 03/11/2013
Decision Date 06/07/2013
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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