# K232189: OrionXR

- Pathway: 510(k) (Traditional)
- Applicant: Hoth Intelligence, Inc.
- Decided: Sep 14, 2023 after 52 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: 11 generations back to K924630 (1993). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213128: IntraOp VSP Software Device, Xironetic, LLC (2022) Summary page 4.

## Indications for use
OrionXR is a software device for display, manipulation, and evaluation of externally-generated 3D models of patient anatomy through an Augmented Reality Head Mounted Display (HMD) to assist in visualization, planning and communication of treatment options. OrionXR is indicated for use by qualified healthcare professionals including but not restricted to radiologists, non-radiology specialists, physicians, and technologists. Digital models viewed through the HMD are for informational purposes only and not intended for diagnostic use. OrionXR is not intended to guide surgical instrumentation and it is not to be used for stereotactic procedures or surgical navigation. OrionXR software is designed for use with performance-tested hardware specified in the User Manual.

Source page: https://510kreport.com/device/K232189
Methodology: https://510kreport.com/methodology