FDA 510(k) Application Details - K033013

Device Classification Name System, Image Processing, Radiological

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510(K) Number K033013
Device Name System, Image Processing, Radiological
Applicant ALGOTEC SYSTEMS, LTD.
P.O. BOX 6718
EFRAT 90435 IL
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Contact ELI M ORBACH
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 09/26/2003
Decision Date 11/25/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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