FDA 510(k) Application Details - K041763

Device Classification Name System, X-Ray, Mobile

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510(K) Number K041763
Device Name System, X-Ray, Mobile
Applicant SHIMADZU CORP.
20101 SOUTH VERMONT AVE.
TORRANCE, CA 90502-1328 US
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Contact TAKESHI OZAKI
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Regulation Number 892.1720

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Classification Product Code IZL
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Date Received 06/30/2004
Decision Date 07/13/2004
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 Y
Expedited Review



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