# K071554: Volcano S5/S5I Intravascular Imaging and Pressure System

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: Jan 4, 2008 after 211 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K934139 (1995). 43 ancestors in all.
28 later devices descend from it; 2 cite it directly.
1 of 72 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061215: Volcano S51 Family of Imaging Systems, Volcano Corporation (2006) Summary page 2.
- K051920: Volcano S5 Imaging System, Model 804200-001, Volcano Corporation (2005) Summary page 2.
- K041134: Combomap Pressure and Flow System, Volcano Therapeutics, Inc. (2004) Summary page 2.
- K051337: Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus System, Model 8049XX-001, Volcano Corporation (2005) Summary page 2.
- K052348: IN Vision Gold with Spin Vision, Model 891 SV, Volcano Corporation (2005) Summary page 2.
- K000820: Avanar F/X 2.9F Intravascular Ultrasound Imaging Catheter, Model 85700, Endosonics Corp. (2000) Summary page 2.
- K944004: Visions 2.9F Ultrasonic Imaging Catheter (Model 84300), Endosonics Corp. (1995) Summary page 2.
- K902329: Ultra-VU Angioscope, Angiolaz, Inc. (1990) Summary page 2.
- K021219: Smartwire/Smartmap Pressure System, Jomed, Inc. (2002) Summary page 2.
- K070487: Smartwire Pressure Guide Wire, Model 66XX, Volcano Corporation (2007) Summary page 2.
- K042996: Combowire Pressure and Flow Guide Wire, Combotip Pressure and Flow Guide Wire, Volcano Therapeutics, Inc. (2004) Summary page 2.
- K050995: Revolution 45 MHZ Rotational Ivus Imaging Catheter, Volcano Corporation (2005) Summary page 2.
- K965140: Cardiometrics Wavewire/Wavemap Pressure System, Cardio Metrics, Inc. (1997) Summary page 2.
- K963290: Colorflo Option for the Oracle Invision Intravascular Ultrasonic Imaging System, Endosonics Corp. (1997) Summary page 2.
- K965223: Resolve Option for the Oracle in Vision Intravascular Ultrasonic Imaging System, Endosonics Corp. (1998) Summary page 2.
- K031148: IN-Vision Imaging System, Jomed, Inc. (2003) Summary page 2.

## Most influential descendants
- 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
- K133323: Volcano Ifr Modality (2014), 18 descendants of its own
- K150441: Volcano iFR Modality, iFR Scout feature (2015), 9 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

## Indications for use
The Volcano s5/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 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. 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/K071554
Methodology: https://510kreport.com/methodology