FDA 510(k) Application Details - K073062

Device Classification Name System, Image Processing, Radiological

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510(K) Number K073062
Device Name System, Image Processing, Radiological
Applicant GENESIS DIGITAL IMAGING, INC.
1600 MANCHESTER WAY
CORINTH, TX 76210 US
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Contact CARL ALLETTO
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 10/30/2007
Decision Date 03/10/2008
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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