# K201586: XACT Robotic System

- Pathway: 510(k) (Special)
- Applicant: Xact Robotics, Ltd.
- Decided: Jul 9, 2020 after 28 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K001284 (2000). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191332: XACT Robotic System, Xact Robotics, Ltd. (2019) Summary page 4.

## Most influential descendants
- K213759: XACT Robotic System, ACE Model (2022), 0 descendants of its own
- K221116: XACT ACE Robotic System (2022), 0 descendants of its own

## Indications for 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.

Source page: https://510kreport.com/device/K201586
Methodology: https://510kreport.com/methodology