FDA 510(k) Application Details - K973653

Device Classification Name System, Image Processing, Radiological

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510(K) Number K973653
Device Name System, Image Processing, Radiological
Applicant AREEDA ASSOC., LTD.
516 NORTH CURSON AVE.
LOS ANGELES, CA 90036-1814 US
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Contact JOSEPH AREEDA
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 09/25/1997
Decision Date 12/12/1997
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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