# CAAS A-Valve 2.1

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

- Canonical page: <https://devicerts.com/devices/caas-a-valve-2-1>
- Manufacturer: [Pie Medical Imaging B.V.](https://devicerts.com/manufacturers/fda-fei-3003595527) (Netherlands)
- Name in the registry: CAAS A-Valve
- Device class: Class IIa (EU MDD); Class II (US FDA)
- FDA product code: LLZ
- EMDN: Z11039082 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES
- GMDN: Radiology DICOM image processing application software (57812)

## Overview

*AI-generated summary, 2026-09-19. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The CAAS A-Valve 2.1 is a measuring device (Nomenclature Code: Z11039082) designed for cardiovascular analysis, specifically for assessing aortic valve function and morphology. It provides quantitative measurements to support clinical decision-making in structural heart disease evaluation, including valve area, gradient, and effective orifice area calculations.

This device is supplied as a non-sterile, non-reusable software-based solution for use in clinical or research settings. It operates on compatible imaging platforms and requires no reprocessing or sterilization. The CAAS A-Valve 2.1 is authorized under FDA 510K and MDD compliance, with a Basic UDI of B-08056304454270. It is classified as Class IIa and includes a unique UDI for traceability.

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-08056304454270 · UDI-DI 08056304454270 · registered 2022-08-18 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 08056304454270 · listed 2020-05-19 · status: Listed (GUDID: in commercial distribution)
- **510(k)** · FDA 510(k) · United States · K143044 · issued 2015-02-06 · status: Active
- **510(k)** · FDA 510(k) · United States · K113076 · issued 2012-01-30 · status: Active
- **510(k)** · FDA 510(k) · United States · K052988 · issued 2005-12-30 · status: Active

## Recalls

No recall on record.

## Identity

- Generic name: Radiology DICOM image processing application software [FDA GUDID (AccessGUDID)]
- Model / reference: CAAS A-Valve [EUDAMED]; 2.1 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 08056304454270 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-08056304454270 [EUDAMED]
- 510(k) Number: K143044 [FDA GUDID (AccessGUDID)]
- FDA product code: LLZ [FDA GUDID (AccessGUDID)]
- EMDN code: Z11039082 [EUDAMED]
- GMDN term: Radiology DICOM image processing application software (57812) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 892.2050 [FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: Netherlands [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Measuring function: Yes [EUDAMED]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: CAAS A-Valve 2.1, Pie Medical Imaging B.V. deviCERTS medical device catalogue. https://devicerts.com/devices/caas-a-valve-2-1 (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-24
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/caas-a-valve-2-1.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-a-valve-2-1
- 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.