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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K945388
Device Name DFS-700
Applicant
Shimadzu Corp.
20101 S. Vermont Ave.
Torrance,  CA  90502
Applicant Contact MICHAEL FISHBACK
Correspondent
Shimadzu Corp.
20101 S. Vermont Ave.
Torrance,  CA  90502
Correspondent Contact MICHAEL FISHBACK
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/03/1994
Decision Date 01/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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