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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 K143122
Device Name Volcano iFR Harvest Software (Offline)
Applicant
Volcano Corporation
3721 Valley Centre Dr.., Suite 500
San Diego,  CA  92130
Applicant Contact Neeta Sharma
Correspondent
Volcano Corporation
3721 Valley Centre Dr.., Suite 500
San Diego,  CA  92130
Correspondent Contact Neeta Sharma
Regulation Number892.1560
Classification Product Code
IYO  
Date Received10/31/2014
Decision Date 02/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Clinical Trials NCT01740895
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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