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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 K881674
Device Name SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC
Applicant
Shimadzu Precision Instruments, Inc.
20410 Earl St.
Torrance,  CA  90503
Applicant Contact HIROYUKI HATTORI,PHD
Correspondent
Shimadzu Precision Instruments, Inc.
20410 Earl St.
Torrance,  CA  90503
Correspondent Contact HIROYUKI HATTORI,PHD
Regulation Number892.1750
Classification Product Code
JAK  
Date Received04/18/1988
Decision Date 09/02/1988
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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