# K250160: Ankyras

- Pathway: 510(k) (Traditional)
- Applicant: Mentice Spain S.L.
- Decided: May 6, 2025 after 105 days
- Product code: PZO (Software For Visualization Of Vascular Anatomy And Intravascular Devices)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K954678 (1996). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230006: Ankyras, Mentice Spain S.L. (2023) Summary page 5.

## Indications for use
ANKYRAS enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. ANKYRAS also allows for the ability to computationally model the placement of neurointerventional braided endovascular devices. General functionalities are provided such as: • Segmentation of neurovascular structures* • Semi-automatic centerline generation from segmented blood vessels* • Visualization of X-ray based images* • Placing and sizing tools for braided endovascular devices • Save user data • Download** and share simulation*** Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider´s judgment and analysis of the patient´s condition. ANKYRAS is available in different platforms: Standalone, WebGL and Mobile App. *Available for Standalone and WebGL platforms **Available for WebGL platform ***Available for WebGL and Mobile App platforms

Source page: https://510kreport.com/device/K250160
Methodology: https://510kreport.com/methodology