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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 K915715
Device Name CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER
Applicant
Ausonics Pty , Ltd.
1140 Nineteenth St., NW
Washington,  DC  20036
Applicant Contact RICHARD S MOREY
Correspondent
Ausonics Pty , Ltd.
1140 Nineteenth St., NW
Washington,  DC  20036
Correspondent Contact RICHARD S MOREY
Regulation Number892.1560
Classification Product Code
IYO  
Date Received10/08/1991
Decision Date 07/02/1992
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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