# CAAS II QVA

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/caas-ii-qva-llz>
- Manufacturer: [Pie Medical Imaging BV](https://devicerts.com/manufacturers/fda-fei-3003595527) (Netherlands)
- Device class: Class II (US FDA)
- FDA product code: LLZ

## Overview

*AI-generated summary, 2026-09-22. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

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.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K012475 · decision 2001-10-24 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K012475 [FDA 510(k)]
- FDA product code: LLZ [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.2050 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: CAAS II QVA, Pie Medical Imaging BV. deviCERTS medical device catalogue. https://devicerts.com/devices/caas-ii-qva-llz (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/caas-ii-qva-llz.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/caas-ii-qva-llz
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.