FDA 510(k) Application Details - K955092

Device Classification Name System, Image Processing, Radiological

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510(K) Number K955092
Device Name System, Image Processing, Radiological
Applicant CEMAX-ICON, INC.
47281 MISSION FALLS CT.
FREMONT, CA 94539 US
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Contact LINDA J MOORE
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 11/07/1995
Decision Date 05/09/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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