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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K863364
Device Name DIAGNOSTIC ULTRASONIC TRANSDUCER
Applicant
Toshiba Medical Systems
2441 Michelle
P.O. Box 2068
Tustin,  CA  92680
Applicant Contact IKUSE
Correspondent
Toshiba Medical Systems
2441 Michelle
P.O. Box 2068
Tustin,  CA  92680
Correspondent Contact IKUSE
Regulation Number892.1570
Classification Product Code
ITX  
Date Received09/02/1986
Decision Date 02/27/1987
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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