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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, Angiographic
510(k) Number K033184
Device Name LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400
Applicant
Shimadzu Corp.
20101 S. Vermont Ave.
Torrance,  CA  90502
Applicant Contact TAKESHI OZAKI
Correspondent
Shimadzu Corp.
20101 S. Vermont Ave.
Torrance,  CA  90502
Correspondent Contact TAKESHI OZAKI
Regulation Number892.1600
Classification Product Code
IZI  
Date Received10/01/2003
Decision Date 12/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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