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CAAS MRV

FDA 510(k)

Class II (US FDA 510(k))

510(k) K041682

by Pie Medical Imaging BV

Identifiers

510(k) Number
K041682 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)

CAAS MRV is a cardiovascular analysis software system that enables the analysis of the function and condition of the heart and peripheral arteries. This software package offers several workflows for analyzing 3D PC-MR images of the heart and major vessels, including the Caas MR 4D Flow functionality.

The system is supplied by Pie Medical Imaging BV and is used for quantitative analysis in cardiology and radiology. It is a reusable software system that aids in diagnostics, patient treatment, and research studies. The device has FDA 510K clearance with product code LLZ and was authorized on 2004-07-27.

Frequently asked questions

What is the CAAS MRV system used for?

CAAS MRV is a cardiovascular analysis software system that enables the analysis of the function and condition of the heart and peripheral arteries. It offers workflows for analyzing 3D PC-MR images of the heart and major vessels, including the Caas MR 4D Flow functionality.

How is the CAAS MRV system supplied?

The CAAS MRV system is supplied by Pie Medical Imaging BV. It is a reusable software system that aids in diagnostics, patient treatment, and research studies in cardiology and radiology departments.

What regulatory approvals does the CAAS MRV have?

The CAAS MRV has FDA 510K clearance with product code LLZ. It was authorized on July 27, 2004, and is classified as substantially equivalent under the traditional clearance pathway.

What are the key features of the CAAS MRV system?

The CAAS MRV system provides several workflows for analyzing 3D PC-MR images of the heart and major vessels. It includes the Caas MR 4D Flow functionality and is designed for quantitative analysis in clinical and research settings.

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, Caas MR Solutions - Pie Medical Imaging, MRV | MR Flow - Pie Medical Imaging - PDF Catalogs | Technical ..., Pie Caas MRV - allmed.wiki

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) K041682 24 fields · synced Sep 23, 2026