# K083745: The IC-Pro System, Model Version 3.2

- Pathway: 510(k) (Traditional)
- Applicant: Paieon, Inc.
- Decided: Feb 17, 2009 after 63 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K926514 (1993). 65 ancestors in all.
30 later devices descend from it; 4 cite it directly.
6 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082907: IC-Pro System, Version 3.1.0.4, Paieon, Inc. (2008) Summary page 1.
- K081379: Modification to Inreach System, Superdimension, Ltd. (2008) Summary page 1.
- K060483: Volcano Angio-Ivus Mapping (Aim) System, Volcano Corporation (2006) Summary page 1.
- K062192: Ostial Pro Stent Positioning System, Ostial Solutions, LLC (2007) Summary page 1.

## Most influential descendants
- 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
- K151780: CAAS Workstation (2016), 9 descendants of its own

## Indications for use
IC-PRO, an image acquisition and processing modular software package, is indicated for use as follows: Assists in the evaluation of coronary lesions by enabling the creation of 3D images of coronary vessel segments based on two to three 2D angiography images obtained from single plane angiography. Provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image. Performs quantitative analysis of the left ventricle based on left ventricular angiograms. Enhances visualization of the stent deployment region and provides quantitative data based on manual stent tracings Assist in device positioning by providing real time localization on predefined roadmaps. To be used in-procedure in the catheterization lab and off-line for post-procedural analysis

Source page: https://510kreport.com/device/K083745
Methodology: https://510kreport.com/methodology