# K120282: Cardnav

- Pathway: 510(k) (Traditional)
- Applicant: Paieon, Inc.
- Decided: Dec 10, 2012 after 314 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K935595 (1995). 194 ancestors in all.
No later device cites it as a predicate yet.
1 of 195 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.
- K110746: 4D LV-Analysis 3.0, Tomtec Imaging Systems GmbH (2011) Summary page 1.
- K072090: Siemens Diagnostic Ultrasound Systems, Siemens Medical Solutions USA, Inc., Ultrasound DI (2007) Summary page 1.

## Cited in the summary but kept off the family tree
- K103615: Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine Reagent, Inorganic Phosphorus U.V. Reagent,Urine Standard, Alfa Wassermann Diagnostic Technologies, Inc. (2011). Our reading of the summary gave K103615, FDA’s number for Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent… (Alfa Wassermann Diagnostic Technologies, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Cardiac Motion Quantification Plugin (CMQ), part of the QLAB…”. Kept off the family tree. Summary page 1.

## Indications for use
CardNav, an image acquisition and processing modular software package, is indicated for use as follows: Assist in projection selection using 3D modeling based on 2D images. Perform quantitative analysis on coronary veins based on fluoroscopy images. Assists in device positioning by providing real time localization on predefined roadmaps and live fluoroscopy. Perform motion analysis on coronary veins based on fluoroscopy images. To be used in cardiac procedures and off-line for post-procedural analysis.

Source page: https://510kreport.com/device/K120282
Methodology: https://510kreport.com/methodology