FDA 510(k) Application Details - K092125

Device Classification Name System, Image Processing, Radiological

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510(K) Number K092125
Device Name System, Image Processing, Radiological
Applicant REAONIX SECURITY, LLC
2434 MALDEN PARK DRIVE
BUFORD, GA 30519 US
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Contact GERALD JACKSON
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 07/15/2009
Decision Date 12/10/2009
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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