# K110256: The IC-Pro System

- Pathway: 510(k) (Traditional)
- Applicant: Paieon, Inc.
- Decided: May 27, 2011 after 119 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: 11 generations back to K926514 (1993). 94 ancestors in all.
15 later devices descend from it; 4 cite it directly.
1 of 110 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083745: The IC-Pro System, Model Version 3.2, Paieon, Inc. (2009) Summary page 1.
- K040254: Integris 3D-RA, Release 4.2, Philips Medical Systems North America Co. (2004) Summary page 1.
- K040305: VITREA2 Version 3.5, Vital Images, Inc. (2004) Summary page 1.
- K040876: Iconnection, Version 3.2.0.0 Medical Image Processing Software, Vital Images, Inc. (2004) Summary page 1.

## Most influential descendants
- K133993: Caas Workstation (2014), 10 descendants of its own
- K151780: CAAS Workstation (2016), 9 descendants of its own
- K180019: CAAS Workstation (2018), 8 descendants of its own
- K182611: Qangio XA 3D (2019), 4 descendants of its own
- K210093: AccuFFRangio (2021), 2 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. Assists in projection selection using 3D modeling based on 2D images. Performs dimensional measurement on DICOM image. To be used in-procedure in the catheterization lab and off-line for post-procedural analysis

Source page: https://510kreport.com/device/K110256
Methodology: https://510kreport.com/methodology