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MRA-CMS

FDA 510(k)

Class II (US FDA 510(k))

510(k) K040746

by Medis Medical Imaging Systems bv

Identifiers

510(k) Number
K040746 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

MRA-CMS is a medical imaging system for quantitative analysis of cardiac imaging data. It is designed to support healthcare professionals in the analysis of images from CT, MRI, X-Ray, and Ultrasound modalities.

The device is supplied as medical software and has received FDA 510(k) clearance under K040746. It is intended for use in clinical settings for cardiovascular imaging analysis and is distributed by Medis Medical Imaging Systems BV.

Frequently asked questions

What is the MRA-CMS used for?

The MRA-CMS is designed to support healthcare professionals in the quantitative analysis of cardiac imaging data, enabling analysis of images from CT, MRI, X-Ray, and Ultrasound modalities in clinical settings for cardiovascular imaging analysis.

How is the MRA-CMS supplied and is it reusable?

The MRA-CMS is supplied as medical software, which means it is distributed electronically or via digital media for installation on compatible hardware; as software, it is not a physical device subject to reuse in the traditional sense, but its use depends on the underlying system and licensing terms.

What regulatory clearance does the MRA-CMS have?

The MRA-CMS has received FDA 510(k) clearance under submission number K040746, which was granted on June 8, 2004, following a traditional review process and found to be substantially equivalent to a predicate device.

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: Cardiac Imaging Software - Medis Medical Imaging, Medis Mra-CMS - allmed.wiki, Quality and Regulatory Information - Medis Medical Imaging, MRA-CMS (K040746) — FDA 510 (k) | Innolitics

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) K040746 24 fields · synced Oct 1, 2026