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CAAS II QVA

FDA 510(k)

Class II (US FDA 510(k))

510(k) K012475

by Pie Medical Imaging BV

Identifiers

510(k) Number
K012475 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)

The CAAS II QVA is a software application designed for quantitative vascular analysis, focusing on peripheral vessels such as the abdominal aorta, carotid, renal, iliac, and femoral arteries. It provides single vessel analysis with features like calibration, contour detection, and quantification of stenosis severity to support diagnosis and treatment selection.

The device is supplied as a workstation and is intended for use in clinical and research settings. It is not specified as single-use or reusable, and no specific storage conditions are provided. The CAAS II QVA is FDA 510(k) cleared and adheres to internationally accepted standards.

Frequently asked questions

What is the CAAS II QVA software used for?

The CAAS II QVA is a software application designed for quantitative vascular analysis of peripheral vessels such as the abdominal aorta, carotid, renal, iliac, and femoral arteries. It provides features like calibration, contour detection, and stenosis severity quantification to support diagnosis and treatment selection.

How is the CAAS II QVA supplied?

The CAAS II QVA is supplied as a workstation intended for use in clinical and research settings. The device is not specified as single-use or reusable, and no specific storage conditions are provided in the available information.

What regulatory approvals does the CAAS II QVA have?

The CAAS II QVA is FDA 510(k) cleared with K number K012475, determined to be substantially equivalent to predicate devices. It was reviewed by the Radiology Advisory Committee and adheres to internationally accepted standards.

What vessels can be analyzed using the CAAS II QVA?

The CAAS II QVA is designed for quantitative analysis of peripheral vessels including the abdominal aorta, carotid arteries, renal arteries, iliac arteries, and femoral arteries, providing single vessel analysis capabilities.

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: QVA :: Pie medical imaging, Caas Workstation - Pie Medical Imaging, CAAS QVA - Pie Medical Imaging - PDF Catalogs | Technical Documentation

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) K012475 24 fields · synced Sep 22, 2026