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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 K080701
Device Name SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION
Applicant
SHIMADZU CORP.
20101 SOUTH VERMONT AVE.
TORRANCE,  CA  90502 -1328
Applicant Contact DON KARLE
Correspondent
SHIMADZU CORP.
20101 SOUTH VERMONT AVE.
TORRANCE,  CA  90502 -1328
Correspondent Contact DON KARLE
Regulation Number892.1720
Classification Product Code
IZL  
Date Received03/11/2008
Decision Date 05/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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