FDA 510(k) Application Details - K070080

Device Classification Name System, Image Processing, Radiological

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510(K) Number K070080
Device Name System, Image Processing, Radiological
Applicant INTELERAD MEDICAL SYSTEMS INC.
460 STE-CATHERINE WEST
SUITE 210
MONTREAL QUEBEC M3B 1A7 CA
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Contact ANIBAL JODORCOVSKY
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 01/09/2007
Decision Date 01/24/2007
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 Y
Expedited Review



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