# K113594: C-THV System

- Pathway: 510(k) (Traditional)
- Applicant: Paieon, Inc.
- Decided: Mar 2, 2012 after 88 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: 12 generations back to K926514 (1993). 95 ancestors in all.
No later device cites it as a predicate yet.
1 of 96 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110256: The IC-Pro System, Paieon, Inc. (2011) Summary page 1.

## Indications for use
C-THY, an image acquisition and processing modular software package, is indicated for use as follows: C-THY, an image acquisition and processing modular software package, is indicated for use as follows: * Assists in projection selection using 3D modeling based on 2D images * Performs dimensional measurements based on DICOM images. * Assists in device positioning by providing real time localization on predefined roadmaps and live fluoroscopy. The system is to be used in-procedure and off-line for post-procedural analysis.

Source page: https://510kreport.com/device/K113594
Methodology: https://510kreport.com/methodology