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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 K923273
Device Name AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
Acoustic Imaging Technologies Corp.
10027 S. 15st St.
Phoenix,  AZ  85044
Applicant Contact LORI CADWELL
Correspondent
Acoustic Imaging Technologies Corp.
10027 S. 15st St.
Phoenix,  AZ  85044
Correspondent Contact LORI CADWELL
Regulation Number892.1560
Classification Product Code
IYO  
Date Received07/06/1992
Decision Date 12/27/1994
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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