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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K151904
Device Name SyncVision System
Applicant
VOLCANO CORPORATION
1 FORTUNE DR.
BILLERICA,  MA  01821
Applicant Contact ELAINE ALAN
Correspondent
VOLCANO CORPORATION
1 FORTUNE DR.
BILLERICA,  MA  01821
Correspondent Contact ELAINE ALAN
Regulation Number892.1650
Classification Product Code
OWB  
Date Received07/13/2015
Decision Date 07/31/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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