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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mobile
510(k) Number K041763
Device Name SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES
Applicant
SHIMADZU CORP.
20101 SOUTH VERMONT AVE.
TORRANCE,  CA  90502 -1328
Applicant Contact TAKESHI OZAKI
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number892.1720
Classification Product Code
IZL  
Date Received06/30/2004
Decision Date 07/13/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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