FDA 510(k), K173860, 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

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