# K123898: Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: Jan 14, 2013 after 27 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 10 (0 Class I)
- 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.
21 later devices descend from it; 3 cite it directly.
0 of 68 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)

## Cited in the summary but kept off the family tree
- K113486: Volcano S5I Intravascular Ultracound Imaging and Pressure System, Volcano Corporation (2012). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K133323: Volcano Ifr Modality (2014), 18 descendants of its own
- K150441: Volcano iFR Modality, iFR Scout feature (2015), 9 descendants of its own
- K170133: FFR V2.5 (2017), 5 descendants of its own
- 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 (2018), 4 descendants of its own
- K183099: QUANTIEN Measurement System (2019), 3 descendants of its own

## Recalls of this device
- Nov 3, 2017 · Class II · Z-0189-2018: On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during use, and the users response to the dialog may adversely affect the subsequent operation of the device.
- Apr 25, 2016 · Class II · Z-1813-2016: Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected data from the hospital
- Jun 22, 2015 · Class II · Z-2135-2015: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
- Jun 22, 2015 · Class II · Z-2132-2015: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
- Jun 22, 2015 · Class II · Z-2134-2015: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
- Jun 22, 2015 · Class II · Z-2131-2015: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
- Jun 22, 2015 · Class II · Z-2136-2015: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
- Jun 22, 2015 · Class II · Z-2133-2015: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
- Sep 23, 2013 · Class II · Z-2043-2015: A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Fl
- Sep 23, 2013 · Class II · Z-2044-2015: A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Fl

## Indications for use
The Volcano s5TM/s5i® 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 vasculatufe. The Volcano VH IV-US System is intended to semi-automatically visualize boundary features and perform spectral 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/K123898
Methodology: https://510kreport.com/methodology