# K223125: XR90 (XR90-Sys)

- Pathway: 510(k) (Traditional)
- Applicant: Mediview Xr, Inc.
- Decided: Jul 13, 2023 after 283 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: 2 generations back to K193149 (2019). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210072: HOLOSCOPE-i, Real View Imaging, Ltd. (2021) Summary page 4.

## Most influential descendants
- K253486: SKIA-Head (Model: SKIA-ST00) (2026), 0 descendants of its own

## Indications for use
The XR90 (XR90-SYS) is a medical display workstation intended for 3D image visualization and image interaction in conjunction with traditional imaging and monitors. The virtual images are generated from tracked Ultrasound, tracked interventional device, and 3D volumetric data acquired from CT sources and stereoscopically projected such that the proximity of the virtual interventional device is displayed relative to live ultrasound and 3D models from previously acquired CT. The device is intended to provide visual information and reference to be used by the health care professionals for analysis of surgical options during pre-operative planning, and the heads-up, intra-operative display of the images during ultrasound-guided needle-based procedures. Virtual images on the heads-up display should always be used in conjunction with traditional monitors. The XR90 (XR90-SYS) system is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis. The XR90 (XR90-SYS) system is intended to be used as a reference display for consultation and guidance to assist the clinician who is responsible for making all final patient management decisions. During system use, the position and orientation tracking of the interventional instruments should always be available to the clinician on traditional imaging and monitors.

Source page: https://510kreport.com/device/K223125
Methodology: https://510kreport.com/methodology