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510(k) Data Aggregation
K Number
K221116Device Name
XACT ACE Robotic System
Manufacturer
Date Cleared
2022-05-13
(28 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) guided 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 quides (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. 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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K Number
K201586Device Name
XACT Robotic System
Manufacturer
Date Cleared
2020-07-09
(28 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 Robotic System, ACE Model 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 Robotic System is a user-controlled positioning system intended to assist in the planning and advancement of instruments during Computed Tomography (CT) guided 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. The system also allows for monitoring of motion associated with respiration during the procedure.
The XACT Robotic System, ACE Model comprises the following main components:
- . XACT Robot which is placed on the patient and includes the robot positioning unit & the insertion module assembly
- . XACT 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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K Number
K191332Device Name
XACT Robotic System
Manufacturer
Date Cleared
2019-10-03
(140 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 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 Robotic System is a user-controlled positioning system intended to assist in the planning and advancement of instruments during Computed Tomography (CT) guided 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 quides (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. The system also allows for monitoring of motion associated with respiration during the procedure.
The XACT Robotic System comprises the following main components:
- . XACT Robot Positioning Unit & Insertion Module Assembly which is placed on the patient
- XACT Control Unit (Central Computer) .
- . XACT Computer Work Station which includes the user interface for trajectory planning and review of instrument position
- XACT System Cart ●
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