FDA 510(k) Application Details - K063548

Device Classification Name System, Image Processing, Radiological

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510(K) Number K063548
Device Name System, Image Processing, Radiological
Applicant RCADIA MEDICAL IMAGING LTD.
DERECH YAFO 157
HAIFA 35251 IL
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Contact DAN LAOR
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 11/24/2006
Decision Date 01/22/2007
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 N
Expedited Review



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