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Ankyras

by Mentice Spain S.L.

510(k) K230006

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK230006 Date28 Dec 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

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  • Withdrawn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
PZO
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

Ankyras is software for visualization of vascular anatomy and intravascular devices, intended to be used by physicians trained in medical procedures involving percutaneous and intravascular interventions. It facilitates a multi-faceted environment accessed via desktop, web, and mobile, providing operating physicians with convenience and immediate access ranging from pure visualization to complete workflow control.

Ankyras enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery, and allows for the ability to computationally model the placement of neurointerventional braided devices. The device is manufactured by Mentice Spain S.L. and has received FDA 510(k) clearance with the product code PZO.

Other devices from Mentice Spain S.L.

Questions

AI-generated answers, 6 Oct 2026

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

  • What is Ankyras software used for?

    Ankyras is a software designed for visualization of vascular anatomy and intravascular devices, specifically for cerebral blood vessels. It assists physicians in preoperational planning and sizing for neurovascular interventions and surgery, and allows computational modeling of neurointerventional braided device placement.

  • How is Ankyras software accessed and what platforms does it support?

    Ankyras provides a multi-faceted environment accessible via desktop, web, and mobile platforms. This design offers operating physicians convenience and immediate access ranging from pure visualization to complete workflow control, depending on their needs during medical procedures.

  • What is the regulatory status of Ankyras software?

    Ankyras has received FDA 510(k) clearance with product code PZO. It is classified as a Class II device for Software for Visualization of Vascular Anatomy and Intravascular Devices, with the clearance granted on December 28, 2023.

  • Who should use Ankyras software and what training is required?

    Ankyras is intended to be used by physicians who are specifically trained in medical procedures involving percutaneous and intravascular interventions. The software requires medical expertise to properly interpret the visualization data and apply it to clinical decision-making during neurovascular procedures.