Quality and Regulatory Compliance

XACT Robotics Quality Policy:

The XACT Way

Patients and their families give every one of our developments a purpose. Every investment has a soul. Every product has a pulse. The ability to improve patients’ lives is a powerful tool, it is the spirit of our company, and it defines our future.

Each of our customers is considered a partner. We focus on creating extraordinary partnerships and helping our partners deliver better care safely and efficiently. Together we can improve patients’ lives across the globe.

Our employees have professional and personal growth opportunities to allow them to meet their career aspirations. Exceptional teamwork will always be at the core of our business, we accept failure as a part of success, and we can achieve the impossible by depending on our team.

We have the power to improve patients’ lives for decades to come. We support a better healthcare system. We are developing future leaders. We will continue to benefit all our stakeholders and shareholders.

And we know that nothing can be better than this.

XACT Robotics Quality Management System policies are defined in accordance with the framework of FDA Quality System Regulation (21 CFR Part 820) and ISO 13485.

Quality Management System Qualifications:

XACT Robotics is certified for ISO 13485 by MEDCERT (Notify Body), see ISO 13485 certification here

XACT Robotics is HIPAA compliant

Regulatory Registrations:

XACT ACE Robotic System and accessories are cleared by FDA under the 510(k) Clearance path. See FDA 510(K) pre-market notification database for more information on the company different 510(k) clearances here 

XACT Robotics system is CE approved under MDD 93/42/EEC by MEDCERT Notify Body and is in process of transitioning to MDR (EU)2017/745. See CE certificates here and here

XACT ACE Robotic System Indication for Use:

The XACT ACE Robotic System is a user-controlled positioning System intended to assist in the planning and advancement of an instrument during Computed Tomography (CT) guided percutaneous procedures. 

The System is used for trajectory planning and is intended to assist the physician in positioning an instrument, such as a needle, where CT imaging is used for Target trajectory planning and intraoperative tracking. 

Important Safety Information on XACT ACE Robotic System:

Please refer to the XACT ACE Robotic System Operator’s Manual for detailed performance specifications and system related hazards and cautions.