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CAAS A-Valve 2.1

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 2.1Model CAAS A-Valve

by Pie Medical Imaging B.V.

Identity

Trade Name
CAAS A-Valve EUDAMEDFDA UDI
Generic Name
Radiology DICOM image processing application software FDA UDI
Device Name
CAAS A-Valve 2.1 EUDAMED
Model / Reference
CAAS A-Valve EUDAMED
2.1 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
08056304454270 EUDAMEDFDA UDI
Basic UDI-DI
B-08056304454270 EUDAMED
510(k) Number
K143044 FDA UDI
FDA Product Code
LLZ FDA UDI
EMDN Code
Z11039082 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
GMDN Term
Radiology DICOM image processing application software FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Special Device Type
-1192 EUDAMED
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

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.

Frequently asked questions

What clinical evaluations can the CAAS A-Valve 2.1 perform, and how does it support decision-making in cardiovascular care?

The CAAS A-Valve 2.1 is designed for quantitative analysis of aortic valve function and morphology, enabling measurements like valve area, pressure gradients, and effective orifice area. These metrics help clinicians assess structural heart disease and guide treatment decisions, such as determining the need for interventions like transcatheter aortic valve replacement (TAVR) or surgical repair.

Is the CAAS A-Valve 2.1 a single-use or reusable device, and what does that mean for my workflow?

The CAAS A-Valve 2.1 is a non-reusable, software-based solution, meaning it does not require reprocessing or sterilization between uses. Since it is non-sterile, it is intended for use in controlled clinical or research environments where contamination risks are managed. This design simplifies workflows by eliminating the need for cleaning or sterilization steps.

How is the CAAS A-Valve 2.1 supplied, and what system compatibility should I check before purchasing?

The CAAS A-Valve 2.1 is supplied as a standalone software solution and requires integration with compatible imaging platforms to function. Before purchasing, verify that your existing imaging system supports its operation, as it relies on those platforms to perform its quantitative cardiovascular analyses.

What regulatory pathways has the CAAS A-Valve 2.1 followed, and how does that affect its use in my facility?

The CAAS A-Valve 2.1 has been authorized under both FDA 510K and MDD compliance pathways, confirming its adherence to regulatory standards in the U.S. and European markets. This means it meets the necessary requirements for use in clinical settings in those regions, though you should confirm local compliance with your facility’s procurement and regulatory policies.

Does the CAAS A-Valve 2.1 require any special storage conditions, and how should it be handled?

As a non-sterile, non-reusable software-based device, the CAAS A-Valve 2.1 does not have strict sterility or storage requirements beyond standard IT and software maintenance. Ensure the device’s hardware and software are protected from physical damage, environmental extremes, and unauthorized access. Follow the manufacturer’s guidelines for software updates and system compatibility to maintain optimal performance.

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, A-valve - piemedicalimaging.com, Pie Caas A-Valve - allmed.wiki, 3mensio Medical Imaging B.V.

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Pie Medical Imaging B.V.
EUDAMED SRN
NL-MF-000001540

Sources (3)

  • EUDAMED b492fe97-fc9d-40c6-a952-232feb8894bc 61 fields · synced Sep 19, 2026
  • FDA UDI bc12598a-7b23-455f-be16-0441c879b722 33 fields · synced May 30, 2026
  • FDA 510(k) K052988 1 fields · synced May 18, 2026