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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collimator, Manual, Radiographic
510(k) Number K101036
Device Name SHIMADZU COLLIMATOR R-20J
Applicant
SHIMADZU CORP.
20101 SOUTH VERMONT AVE.
TORRANCE,  CA  90502 -1328
Applicant Contact DONALD KARLE
Correspondent
SHIMADZU CORP.
20101 SOUTH VERMONT AVE.
TORRANCE,  CA  90502 -1328
Correspondent Contact DONALD KARLE
Regulation Number892.1610
Classification Product Code
IZX  
Date Received04/14/2010
Decision Date 08/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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