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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 K970047
Device Name PHASED ARRAY TRANSDUCER - - PSK-20CT
Applicant
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781 -2068
Applicant Contact STEVEN M KAY
Correspondent
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781 -2068
Correspondent Contact STEVEN M KAY
Regulation Number892.1570
Classification Product Code
ITX  
Date Received01/06/1997
Decision Date 03/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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