# K062386: Qangio CT

- Pathway: 510(k) (Traditional)
- Applicant: Medis Medical Imaging Systems BV
- Decided: Oct 5, 2006 after 51 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002519 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040746: Mra-CMS, Medis Medical Imaging Systems BV (2004) Summary page 1.

## Indications for use
QAngio CT software solution has been developed for the objectie and reproducible analysis of vessels in CTA images. It enables the quantitative analysis of CT angiograms based on automated segmentation. More specifically, QAngio CT can be used to quantify a number of lesion characteristics. QAngio CT is intended for use as an auxiliary tool in assessing CTA studies in clinical practice and in clinical trials. The analysis results obtained with QAngio CT are to be interpreted by cardiologists and radiologists.

Source page: https://510kreport.com/device/K062386
Methodology: https://510kreport.com/methodology