# K153369: SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: Dec 22, 2015 after 29 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K934139 (1995). 51 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133641: Core Control Pad, Core Series SW V3.4 Installation Kit, Core, Core Mobile, Volcano Corporation (2013) Summary page 4.
- K140291: Volcano Core Control Pad, Accessory to the Volcano S5/S5I Intravascular Ultrasound Imaging & Pressure Systems, Volcano Corporation (2014) Summary page 4.
- K133323: Volcano Ifr Modality, Volcano Corporation (2014) Summary page 4.
- K150441: Volcano iFR Modality, iFR Scout feature, Volcano Corporation (2015) Summary page 4.

## Most influential descendants
- K170385: CORE M2 Vascular System (2017), 1 descendant of its own
- K172455: CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit (2017), 0 descendants of its own

## Indications for use
The Volcano s5i®/CORE™ and CORE™ Mobile Precision Guided Therapy System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. ChromaFlo® is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion. The VH® IVUS System is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations. The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures. The iFR® Modality of the s5/s5i/CORE and CORE Mobile Precision Guided Therapy System is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures. The iFR® Modality is intended to be used in conjunction with currently marketed Volcano pressure wires. Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vasculature as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and the wall structures. The Pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.

Source page: https://510kreport.com/device/K153369
Methodology: https://510kreport.com/methodology