Ankyras

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 9 Oct 2026.

Model / Reference

6.0

Primary DI / UDI-DI

08437025622023

Basic UDI-DI

8437025622ANKYRASMSPM3

510(k) Number

K250160 ↗

FDA Product Code

PZO

EMDN Code

Z12109082 Various neurology and neurosurgery instruments - software accessories

Device Class

Class IIb EUDAMED

Class II 510(k)

Regulation

21 CFR Part 892.2050

Special Device Type

Software

EU market of registration

Spain

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• ANKYRAS v4.0.4-US

  Class II

  GUDID on market

• Ankyras

  Class II

  FDA 510(k) K230006 Active Cleared 28 Dec 2023

• What types of medical procedures is Ankyras designed to support during imaging?

  Ankyras is specifically designed to enhance visualization during radiology procedures involving vascular structures, such as coronary and peripheral vasculature assessments. It integrates with imaging systems to provide real-time anatomical mapping, aiding in precise navigation and evaluation of blood vessels and intravascular devices.

• Is Ankyras a physical device that requires sterilization, or is it a software solution?

  Ankyras is a standalone software solution and does not require physical sterilization. Since it is a non-invasive digital tool, it operates on compatible imaging platforms without the need for sterilization processes.

• How is Ankyras supplied, and what kind of setup is required for use?

  Ankyras is supplied as a software-only solution, meaning it does not require any physical hardware beyond the existing imaging systems it integrates with. It is intended for use in radiology settings where vascular imaging is performed, ensuring compatibility with existing platforms.

• What regulatory pathways has Ankyras undergone, and what does this mean for its use?

  Ankyras has been authorized through both FDA 510(k) clearance and MDR (Medical Device Regulation) compliance, adhering to Class II regulatory standards. This means it has undergone rigorous evaluation to ensure safety and performance, allowing it to be legally marketed and used in approved radiology settings.

• Does Ankyras come in different sizes or models, or is it a uniform software solution?

  Ankyras is a uniform software solution and does not come in varying sizes or physical models. Its functionality is consistent across its authorized use cases, focusing solely on enhancing vascular visualization in radiology procedures.