FDA 510(k) K173860, s5 and s5i Intravascular Ultrasound and CORE Guided Therapy Systems, by Volcano Corporation
FDA 510(k) K173860, s5 and s5i Intravascular Ultrasound and CORE Guided Therapy Systems, by Volcano Corporation
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
Manufacturer: Volcano Corporation
Device Classification Name: system, imaging, pulsed echo, ultrasonic
Regulation Number: 892.1560
Classification Product Code: IYO
Date Received: 12/20/2017
Decision Date: 04/11/2018
Regulation Medical Specialty: Radiology
Total pages: 1035
Fully redacted pages: 584
Content pages: 451
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