FDA 510(k) Application Details - K081076

Device Classification Name System, Image Processing, Radiological

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510(K) Number K081076
Device Name System, Image Processing, Radiological
Applicant VELOCITY MEDICAL SOLUTIONS, LLC
1733 CANTON LANE
MARIETTA, GA 30062 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 04/16/2008
Decision Date 06/20/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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