# K213838: AneuGuide

- Pathway: 510(k) (Traditional)
- Applicant: ArteryFlow Technology Co., Ltd.
- Decided: Jun 1, 2022 after 174 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)
- K202322: Sim&Size, Sim&Cure (2020) Summary page 4.

## Indications for use
AneuGuide enables visualization of intracranial vessels for preoperational planning and sizing for neurovascular interventions. AneuGuide also allows for the ability to computationally model the placement of neurointerventional devices. General functionalities are provided such as: • Segmentation of neurovascular structures • Automatic centerline detection • Visualization of X-ray based images for 2D review and 3D reconstruction • Placing and sizing tools • Reporting tools 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.

Source page: https://510kreport.com/device/K213838
Methodology: https://510kreport.com/methodology