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Quantitative Analysis of Left Ventricular Angiograms (QLV)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K993765

by Medis Medical Imaging Systems bv

Identifiers

510(k) Number
K993765 FDA 510(k)
FDA Product Code
IZI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1600 FDA 510(k)
Regulation Number
892.1600 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Quantitative Analysis of Left Ventricular Angiograms (QLV) is a software system designed for X-ray angiographic imaging. It provides quantitative assessment of left ventricular function by analyzing angiographic images to measure parameters such as ejection fraction, end-diastolic volume, and end-systolic volume. This device aids radiologists in evaluating cardiac performance and diagnosing conditions related to ventricular function.

QLV is supplied as a software solution for use in radiology departments, typically integrated with X-ray angiography systems. It operates on compatible hardware platforms and is intended for single-use per analysis session, though the software itself may be reusable across multiple procedures. The device has received FDA 510(k) clearance under the Medical Device Directive (MDD) and is classified as a Class II medical device. No specific sterility or MRI safety information is provided, and its use is regulated under the regulatory framework for X-ray imaging systems.

Frequently asked questions

What clinical parameters does the QLV software analyze in left ventricular angiograms, and how might these help in patient assessment?

The QLV software measures key cardiac performance metrics such as ejection fraction, end-diastolic volume, and end-systolic volume. These parameters quantify left ventricular function, helping radiologists assess cardiac health, diagnose conditions like heart failure or cardiomyopathies, and monitor treatment progress by providing objective, quantitative insights into ventricular performance.

Is the QLV software designed for single-use or reusable across multiple procedures, and how does this impact workflow?

QLV is intended for single-use per analysis session, meaning each angiographic evaluation requires a fresh instance of the software. However, the underlying software platform itself is reusable across multiple procedures, allowing radiology departments to deploy it repeatedly without needing to replace the entire system after each use. This design balances usability with workflow efficiency.

What hardware compatibility should I consider when integrating QLV into my radiology department’s existing X-ray angiography systems?

QLV is designed as a software solution that integrates with compatible X-ray angiography systems, but the exact hardware requirements aren’t detailed in the provided data. You’ll need to confirm compatibility with your specific imaging equipment from the manufacturer, Medis Medical Imaging Systems. Ensure your system meets the technical specifications for running the software smoothly.

Does QLV require any special handling or storage conditions, such as sterility or environmental controls?

QLV is a software-based device, so it does not require sterility or physical storage controls like traditional medical hardware. However, since it operates on hardware platforms, those systems should be maintained in a clean, controlled environment to prevent data corruption or interference. No specific environmental conditions (e.g., temperature, humidity) are mentioned for the software itself.

What regulatory pathway was followed for QLV’s clearance, and how does this affect its use in clinical settings?

QLV received FDA 510(k) clearance under the Medical Device Directive (MDD) and is classified as a Class II device. This means it underwent a premarket submission process to demonstrate substantial equivalence to a predicate device, ensuring its safety and effectiveness for its intended use in quantitative left ventricular analysis. Clinicians can rely on this regulatory pathway as evidence of its compliance with U.S. standards for X-ray angiography software.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medis Medical Imaging Systems bv

Sources (2)

  • FDA 510(k) K993765 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026