# K060483: Volcano Angio-Ivus Mapping (Aim) System

- Pathway: 510(k) (Traditional)
- Applicant: Volcano Corporation
- Decided: Jun 23, 2006 after 119 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 K940172 (1994). 7 ancestors in all.
31 later devices descend from it; 2 cite it directly.
5 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031148: IN-Vision Imaging System, Jomed, Inc. (2003) Summary page 1.
- K030139: The Cardiop-B System, Paieon, Inc. (2004) Summary page 1.

## Most influential descendants
- K083745: The IC-Pro System, Model Version 3.2 (2009), 30 descendants of its own
- K110256: The IC-Pro System (2011), 15 descendants of its own
- K100292: Caas Qva 3D, Caas Qca 3D (2010), 13 descendants of its own
- K091781: Guided Medical Positioning System (GMPS) (2009), 11 descendants of its own
- K133993: Caas Workstation (2014), 10 descendants of its own

## Indications for use
The Volcano Angio-IVUS Mapping System is intended to provide a common frame of reference for intravascular ultrasound and angiographic images during diagnostic and/or interventional procedures for the coronary vasculature. The system provides indication of the location of the IVUS cross-sectional imaging plane for any given IVUS image as it relates to a two-dimensional (2D) angiographic image and/or the associated three-dimensional (3D) model formulated from multiple 2D image projections.

Source page: https://510kreport.com/device/K060483
Methodology: https://510kreport.com/methodology