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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 K994431
Device Name SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES
Applicant
SHIMADZU MEDICAL SYSTEMS
20101 SOUTH VERMONT AVE.
TORRANCE,  CA  90502 -1328
Applicant Contact MICHAEL FISHBACK
Correspondent
SHIMADZU MEDICAL SYSTEMS
20101 SOUTH VERMONT AVE.
TORRANCE,  CA  90502 -1328
Correspondent Contact MICHAEL FISHBACK
Regulation Number892.1750
Classification Product Code
JAK  
Date Received12/30/1999
Decision Date 03/23/2000
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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