# K213128: IntraOp VSP Software Device

- Pathway: 510(k) (Traditional)
- Applicant: Xironetic, LLC
- Decided: Oct 21, 2022 after 389 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 10 generations back to K924630 (1993). 50 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172418: OpenSight, Novarad Corporation (2018) Summary page 5.

## Most influential descendants
- K232189: OrionXR (2023), 0 descendants of its own

## Indications for use
IntraOpVSP is a software device that is indicated for use with an augmented reality head-mounted display which allows for visualization and orientation of 3D digital models of selected structures of a patient's anatomy. IntraOpVSP is intended to supplement conventional Virtual Surgical Planning (VSP) by facilitating perception of the shape and scale of a patient’s anatomical targets for use in preoperative planning and heads-up 3D visualization during surgery. IntraOpVSP is not intended to provide diagnosis or to guide surgical instrumentation. It is not to be used for stereotactic procedures or surgical navigation. IntraOpVSP is intended for use by surgeons who have been trained to operate IntraOpVSP. IntraOpVSP software is designed for use with performance-tested hardware specified in the User Manual.

Source page: https://510kreport.com/device/K213128
Methodology: https://510kreport.com/methodology