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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 K123535
Device Name ILAB ULTRASOUND IMAGING SYSTEM
Applicant
Boston Scientific Corp
47215 Lakeview
Fremont,  CA  94538 -6515
Applicant Contact LORI R SMITH
Correspondent
Boston Scientific Corp
47215 Lakeview
Fremont,  CA  94538 -6515
Correspondent Contact LORI R SMITH
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received11/16/2012
Decision Date 01/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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