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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K973767
Device Name HARMONIC IMAGING WITH CONTRAST
Applicant
Acuson Corp.
1220 Charleston Rd.
Mountain View,  CA  94039
Applicant Contact WILLIAM WELCH
Correspondent
Acuson Corp.
1220 Charleston Rd.
Mountain View,  CA  94039
Correspondent Contact WILLIAM WELCH
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received10/02/1997
Decision Date 12/23/1997
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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