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510(k) Data Aggregation
K Number
K213759Device Name
XACT Robotic System, ACE Model
Manufacturer
Date Cleared
2022-09-23
(297 days)
Product Code
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
XACT Robotics, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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 of an instrument, such as a needle, where CT imaging is used for target trajectory planning and intraoperative tracking.
Device Description
The XACT ACE Robotic System is a user-controlled positioning system intended to assist in the planning and advancement of instruments during Computed Tomography (CT) quided percutaneous procedures. The system is used for trajectory planning based on CT images and is intended to assist the physician in positioning of an instrument, such as a needle, and reviewing instrument position during advancement to the target. The system guides (i.e., positions and steers) the instrument according to a predefined trajectory. The physician controls advancement of the instrument along the trajectory using a foot pedal or a pushbutton on the control room console. The system also allows for monitoring of motion associated with respiration during the procedure.
The XACT ACE Robotic System comprises the following main components:
- . XACT ACE Robot which is placed on the patient and includes the robot positioning unit & the insertion module assembly
- . XACT ACE Console which includes a Control Unit, central computer (in the Control Unit) and monitor workstation for user trajectory planning, user interface and review of instrument position
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