Skip to content

CAAS II QVA

by Pie Medical Imaging BV

510(k) K012475

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK012475 Date24 Oct 2001ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LLZ
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from Pie Medical Imaging B.V.

See all devices from Pie Medical Imaging B.V. →