# K113486: Volcano S5I Intravascular Ultracound Imaging and Pressure System

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: Jan 27, 2012 after 65 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: 8 generations back to K934139 (1995). 46 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111706: Volcano S5IINTRAVASCULAR Imaging and Pressure System, Volcano Corporation (2011) Summary page 1.

## Most influential descendants
- K122826: Preview Forward-Looking Ivus Catheter and Laptop System; Preview Catheter Model 87000; Pimf Model 87-Pimf; Laptop System (2013), 1 descendant of its own
- K132659: Volcano Preview Forward-Looking Ivus System (2013), 0 descendants of its own

## Indications for use
The Volcano s5 TM Series Intravascular Imaging and Pressure 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. VH® IVUS 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 spectra! analysis of RIF 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. 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 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/K113486
Methodology: https://510kreport.com/methodology