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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 K884555
Device Name TCT-600HQ COMPU TOMO(CT)XRAY/HEAD/WHOLE BODY EXAM
Applicant
Toshiba Medical Systems
2441 Michelle
P.O. Box 2068
Tustin,  CA  92680
Applicant Contact RONALD B SCHILLING
Correspondent
Toshiba Medical Systems
2441 Michelle
P.O. Box 2068
Tustin,  CA  92680
Correspondent Contact RONALD B SCHILLING
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/31/1988
Decision Date 02/27/1989
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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