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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 K130243
Device Name ILAB ULTRASOUND IMAGING SYSTEM
Applicant
BOSTON SCIENTIFIC CORP.
47215 LAKEVIEW BLVD
FREMONT,  CA  94538 -6515
Applicant Contact LORI R SMITH
Correspondent
BOSTON SCIENTIFIC CORP.
47215 LAKEVIEW BLVD
FREMONT,  CA  94538 -6515
Correspondent Contact LORI R SMITH
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received01/31/2013
Decision Date 03/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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