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Qiva

FDA 510(k)

Class II (US FDA 510(k))

510(k) K021495

by Pie Medical Imaging BV

Identifiers

510(k) Number
K021495 FDA 510(k)
FDA Product Code
DQK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1425 FDA 510(k)
Regulation Number
870.1425 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The QIVA is a Quantitative Intravascular Ultrasound (IVUS) Analysis Software, designed for the automated measurement and analysis of intravascular ultrasound images. It provides quantitative assessments of coronary and peripheral arteries, including lumen dimensions, plaque composition, and vessel wall characteristics, to support clinical decision-making in interventional cardiology.

This software is intended for use in clinical settings by trained medical professionals to analyze IVUS images obtained during percutaneous coronary or peripheral interventions. Supplied as a standalone application, it requires compatibility with IVUS imaging systems and does not specify sterility or single-use/reusability. The device holds FDA 510(k) clearance (K021495) under the DQK product code and is classified under the Cardiovascular advisory committee. No MRI safety or size specifications are provided in the regulatory data.

Frequently asked questions

What clinical applications does the QIVA software support in interventional cardiology?

The QIVA software is designed for automated analysis of intravascular ultrasound (IVUS) images to assess coronary and peripheral arteries. It provides quantitative measurements like lumen dimensions, plaque composition, and vessel wall characteristics, which help clinicians make informed decisions during percutaneous coronary or peripheral interventions. This means it’s primarily used to evaluate artery health and guide procedures such as stent placement or angioplasty.

Is the QIVA software compatible with any specific IVUS imaging systems, or does it require a particular setup?

The QIVA software is supplied as a standalone application but requires compatibility with existing IVUS imaging systems to function. Since it doesn’t specify exact hardware requirements in the regulatory data, users should confirm system integration with their current IVUS equipment before implementation. It’s not a standalone device but rather a tool that analyzes images captured by compatible IVUS systems.

How is the QIVA software distributed, and what kind of training is typically needed for its use?

The QIVA software is distributed as a standalone application, meaning it’s installed on a computer system rather than supplied as a physical device. Given its intended use for quantitative IVUS analysis, it is designed for trained medical professionals—likely cardiologists, interventional radiologists, or specialized technicians—who have experience interpreting IVUS images. While the regulatory data doesn’t specify training requirements, clinical use would logically require familiarity with IVUS imaging and the software’s analytical features.

Does the QIVA software have any limitations regarding its use in specific procedures or patient populations?

The QIVA software is specifically intended for analyzing IVUS images obtained during percutaneous coronary or peripheral interventions, focusing on lumen dimensions, plaque composition, and vessel wall characteristics. Since it doesn’t mention limitations in the regulatory data, its use is generally applicable to these contexts. However, as with any diagnostic tool, its effectiveness depends on the quality of the input images and the expertise of the user interpreting the results. It is not intended for non-invasive or non-IVUS-based assessments.

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: Pie Medical Imaging - Solutions in cardiovascular analysis, Markets - Pie Medical Imaging, Pie Medical Imaging B.V. Company Profile | Maastricht, Limburg ..., QIVA (Quantitative IntraVascular ultrasound Analysis) Software ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pie Medical Imaging BV

Sources (1)

  • FDA 510(k) K021495 24 fields · synced Sep 19, 2026