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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 K173860
Device Name s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System
Applicant
Volcano Corporation
3721 Valley Centre Dr., Suite 500
San Diego,  CA  92130
Applicant Contact Nora York
Correspondent
Volcano Corporation
3721 Valley Centre Dr., Suite 500
San Diego,  CA  92130
Correspondent Contact Kimberly Simon
Regulation Number892.1560
Classification Product Code
IYO  
Date Received12/20/2017
Decision Date 04/11/2018
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
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