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XACT Robotic System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191332

by Xact Robotics Ltd

Identifiers

510(k) Number
K191332 FDA 510(k)
FDA Product Code
JAK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1750 FDA 510(k)
Regulation Number
892.1750 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The XACT Robotic System is a robotic device designed for minimally invasive surgical procedures, enabling precise access to difficult-to-reach anatomical targets such as tumors, lesions, or tissue samples. It operates under the guidance of clinical expertise, utilizing robotic-assisted planning and execution to navigate complex trajectories for enhanced procedural accuracy.

The system is supplied as a reusable medical device and is intended for use in surgical settings, where it is controlled by trained operators. It is approved under FDA 510(k) clearance (K191332) and adheres to radiology-related regulatory pathways. No specific sterility or MRI safety details are provided in the available data.

Frequently asked questions

What types of surgical procedures is the XACT Robotic System designed to assist with, and how does it improve precision?

The XACT Robotic System is specifically designed for minimally invasive surgical procedures where accessing difficult-to-reach anatomical targets—such as tumors, lesions, or tissue samples—is required. It enhances precision by using robotic-assisted planning and execution, allowing trained operators to navigate complex trajectories with greater accuracy during surgery. This reduces the risk of off-target errors and improves control in delicate procedures.

Is the XACT Robotic System intended for single-use or reusable applications, and how should it be maintained?

The XACT Robotic System is supplied as a reusable medical device, meaning it is built for repeated use in surgical settings after proper cleaning, disinfection, and maintenance. Since it is not sterile out-of-the-box, it must be processed according to established institutional protocols for reuse, ensuring compliance with infection control standards before each procedure.

What regulatory pathway was followed for FDA clearance of the XACT Robotic System, and what does this mean for clinicians?

The XACT Robotic System received FDA clearance through a Traditional 510(k) pathway (K191332), determined to be *substantially equivalent* to a legally marketed predicate device. This means the FDA reviewed it against existing robotic-assisted surgical systems and confirmed its safety and effectiveness for the intended use—minimally invasive procedures requiring precise anatomical targeting. Clinicians can rely on this clearance as evidence of regulatory scrutiny before adoption.

Are there specific size or model variations available for the XACT Robotic System, and how might this affect procedure selection?

The provided data does not specify size or model variations for the XACT Robotic System, implying a single primary configuration designed for general use in minimally invasive surgeries. However, its robotic-assisted design suggests adaptability to various anatomical targets, though clinicians should confirm compatibility with their specific surgical needs or consult manufacturer documentation for procedural guidance.

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: Medical Robotics Technology - XACT Robotics, The ACE Robotic System - XACT Robotics, XACT Robotics shuts down, lays off 65 - Globes, Xact Robotics, Ltd. | MTEC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Xact Robotics Ltd
FDA Applicant
Xact Robotics, Ltd.

Sources (1)

  • FDA 510(k) K191332 24 fields · synced Sep 19, 2026