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Qangio Ct

FDA 510(k)

Class II (US FDA 510(k))

510(k) K062386

by Medis Medical Imaging Systems bv

Identifiers

510(k) Number
K062386 FDA 510(k)
FDA Product Code
JAK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1750 FDA 510(k)
Regulation Number
892.1750 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Qangio Ct is a cardiac imaging software solution designed for processing coronary computed tomography angiography (CTA) data. It incorporates medical image processing algorithms for automatic coronary tree extraction, lumen and vessel wall contour detection, and analysis of vessel morphology, intensities, plaque burden, and characterization.

The software is supplied as a research edition and is intended for research purposes only. It is developed and manufactured by Medis Medical Imaging Systems BV in Leiden, the Netherlands, and received FDA 510(k) clearance as a substantially equivalent device under product code JAK, with decision date October 5, 2006.

Frequently asked questions

What is Qangio Ct used for?

Qangio Ct is a cardiac imaging software solution designed for processing coronary computed tomography angiography (CTA) data. It incorporates medical image processing algorithms for automatic coronary tree extraction, lumen and vessel wall contour detection, and analysis of vessel morphology, intensities, plaque burden, and characterization.

How is Qangio Ct supplied and what is its intended use?

The software is supplied as a research edition and is intended for research purposes only. It is developed and manufactured by Medis Medical Imaging Systems BV in Leiden, the Netherlands.

What regulatory clearance does Qangio Ct have?

Qangio Ct received FDA 510(k) clearance as a substantially equivalent device under product code JAK, with decision date October 5, 2006, based on its submission K062386.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF QAngio CT RE 3 - Medis Cardiovascular post-processing software, Cardiac Imaging Software - Medis Medical Imaging, PDF Medis Suite CT QAngio CT RE 3 - Eukon

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medis Medical Imaging Systems bv

Sources (1)

  • FDA 510(k) K062386 24 fields · synced Sep 21, 2026