Devices

Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System

Model / Serial
s5 Part number 804200-002 and 804200-014; s5x Part number 807300-001; CORE MOBILE Part Number 400-0100.01. All software versions
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US Nationwide and the countries of Belgium, United Kingdom, Denmark, Netherlands, Sweden, Iceland, France, Saudi Arabia, Australia, Philippines and Thailand.
Product Description
Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; || s5x - 807300-001; CORE MOBILE - 400-0100.01. || Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
Manufacturer
Volcano Corp
1 Event
- Recall of Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System

Manufacturer

Volcano Corp

Manufacturer Address
Volcano Corp, 3721 Valley Centre Dr Ste 500, San Diego CA 92130-3328
Manufacturer Parent Company (2017)
Philips
Source
USFDA

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