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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 K925965
Device Name PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
Applicant
Advanced Light Imaging Technologies , Ltd.
320-3700 Gilmore Way
Burnaby,
B.C. Canada V5g 4m1,  CA
Applicant Contact KEVIN L JAMES
Correspondent
Advanced Light Imaging Technologies , Ltd.
320-3700 Gilmore Way
Burnaby,
B.C. Canada V5g 4m1,  CA
Correspondent Contact KEVIN L JAMES
Regulation Number892.1560
Classification Product Code
IYO  
Date Received11/25/1992
Decision Date 06/14/1993
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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