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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, Tomography, Computed
510(k) Number K984156
Device Name SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION
Applicant
Shimadzu Medical Systems
20101 S. Vermont Ave.
Torrance,  CA  90502
Applicant Contact MICHAEL FISHBACK
Correspondent
Shimadzu Medical Systems
20101 S. Vermont Ave.
Torrance,  CA  90502
Correspondent Contact MICHAEL FISHBACK
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/19/1998
Decision Date 04/21/1999
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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