# K222664: Sim&Size

- Pathway: 510(k) (Traditional)
- Applicant: Sim&Cure
- Decided: Jan 27, 2023 after 147 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: 12 generations back to K954678 (1996). 13 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212373: Sim&Size, Sim&Cure (2022) Summary page 4.

## Most influential descendants
- K242124: Sim&Size (2024), 1 descendant of its own
- K253122: Sim&Size (2025), 0 descendants of its own

## Indications for use
Sim&Size enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. Sim&Size 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/K222664
Methodology: https://510kreport.com/methodology