# K042188: Volcano Therapeutics, Inc. Volcano Ivus System

- Pathway: 510(k) (Traditional)
- Applicant: Volcano Therapeutics, Inc.
- Decided: Nov 10, 2004 after 90 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: 3 generations back to K934139 (1995). 4 ancestors in all.
48 later devices descend from it; 2 cite it directly.
2 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022824: Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X & Surgical View 1.X, Tomtec Imaging Systems GmbH (2002) Summary page 1.
- K001592: Echocom, Imagecom, Dokucom, Tomtec Imaging Systems GmbH (2000) Summary page 1.

## Most influential descendants
- K051337: Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus System, Model 8049XX-001 (2005), 47 descendants of its own
- K071554: Volcano S5/S5I Intravascular Imaging and Pressure System (2008), 28 descendants of its own
- K082229: S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow System (2008), 25 descendants of its own
- K111706: Volcano S5IINTRAVASCULAR Imaging and Pressure System (2011), 24 descendants of its own
- K123898: Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System (2013), 21 descendants of its own

## Indications for use
The Volcano Therapeutics, Inc. Volcano IVUS System is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano 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.

Source page: https://510kreport.com/device/K042188
Methodology: https://510kreport.com/methodology