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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 K880839
Device Name AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
Phoenix Imaging
4666 S. Ash Ave.
Tempe,  AZ  85282
Applicant Contact MATT HEDLUND
Correspondent
Phoenix Imaging
4666 S. Ash Ave.
Tempe,  AZ  85282
Correspondent Contact MATT HEDLUND
Regulation Number892.1560
Classification Product Code
IYO  
Date Received03/01/1988
Decision Date 06/10/1988
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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