← Back to catalogue

xvision Spine System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241481

by Augmedics Ltd

Identifiers

510(k) Number
K241481 FDA 510(k)
FDA Product Code
SBF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4560 FDA 510(k)
Regulation Number
882.4560 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The xvision Spine System is an Orthopedic Augmented Reality device designed to enhance surgical visualization during spine procedures. It integrates augmented reality technology to overlay anatomical structures, enabling surgeons to navigate instruments and implants with greater precision and accuracy. By providing real-time, three-dimensional imaging, it supports complex interventions such as spinal fusion, decompression, and instrumentation placement.

This system is intended for use in operating rooms during spine surgeries and is supplied as a reusable, non-sterile device. It requires calibration and integration with compatible surgical tools and imaging systems. The xvision Spine System is classified under FDA device class II (SBF) and holds a Traditional 510(k) clearance with the advisory committee designation for Neurology. It is regulated under FDA regulation number 882.4560 and is not intended for MRI use.

Frequently asked questions

What is the xvision Spine System used for?

The xvision Spine System is an Orthopedic Augmented Reality device designed to enhance surgical visualization during spine procedures. It overlays real-time, three-dimensional anatomical structures onto the surgical field, helping surgeons navigate instruments and implants with greater precision. This is particularly useful for complex interventions such as spinal fusion, decompression, and instrumentation placement, where accuracy is critical.

How is the xvision Spine System supplied and what are its sterility and reuse details?

The xvision Spine System is supplied as a reusable, non-sterile device. It is not intended for direct patient contact without proper sterilization procedures, so it must be cleaned and calibrated between uses. The system requires integration with compatible surgical tools and imaging systems to function effectively in the operating room.

Can the xvision Spine System be used with MRI equipment?

No, the xvision Spine System is explicitly not intended for MRI use. This limitation is due to potential interference between the augmented reality technology and MRI environments, which could compromise imaging accuracy or device functionality.

What regulatory pathway does the xvision Spine System follow?

The xvision Spine System is regulated under FDA regulation number 882.4560 and holds a Traditional 510(k) clearance with the advisory committee designation for Neurology. It is classified under FDA device class II (SBF), indicating it is subject to special controls to ensure its safety and effectiveness for spine-related augmented reality applications.

What are the key specifications or models associated with the xvision Spine System?

The xvision Spine System is associated with multiple FEI numbers (e.g., 3002619595, 3004142400, etc.), which correspond to different configurations or components of the system. These identifiers are used for regulatory tracking and ensure compatibility with various surgical tools and imaging systems. The system is designed to work with a range of spine procedures, but specific models or variations may be tailored for particular clinical needs.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: X-Ray Vision for Spine Surgery | Augmedics, Augmented Reality Spine Surgery - X-Ray Vision | Augmedics, VB Spine Announces Intent to Acquire Augmedics' Spine Platform, VB Spine Announces Intent to Acquire Exclusive Rights to Augmedics ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Augmedics Ltd
FDA Applicant
Augmedics, Ltd.

Sources (1)

  • FDA 510(k) K241481 24 fields · synced Oct 1, 2026