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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 K190626
Device Name SyncVision System
Applicant
Volcano Corporation
3721 Valley Centre Dr.., Suite 500
San Diego,  CA  92130
Applicant Contact Rand Daoud
Correspondent
Volcano Corporation
3721 Valley Centre Dr.., Suite 500
San Diego,  CA  92130
Correspondent Contact Rand Daoud
Regulation Number892.1650
Classification Product Code
OWB  
Date Received03/11/2019
Decision Date 04/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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