# CT-guided needle robots and percutaneous navigation (XACT ACE, Epione, MICROMATE, CAS-One IR)

Source: https://onco.cc/technologies/image-guided-percutaneous-robots/  
OnCo record `image-guided-percutaneous-robots` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Robots and navigation systems that plan the path of a biopsy or ablation needle on a CT scan and then hold, aim or steer the needle along it, to reach small targets in the lung, liver or kidney with fewer adjustments.

## Summary

Most are cleared as accessories to CT systems (FDA product code JAK). XACT Robotics' XACT ACE (K221116, 13 May 2022) is "a user-controlled positioning system intended to assist in the planning and advancement of an instrument during Computed Tomography (CT) guided percutaneous procedures". Quantum Surgical's Epione (K211645, 24 February 2022) is a stereotactic accessory for planning and manual advancement, indicated for liver ablation among other uses. Others are iSYS's MICROMATE (K203720, 22 June 2021), Cascination's CAS-One IR (K232022, 13 March 2024), IMACTIS CT-Navigation (K162314, 24 April 2018), Clear Guide's SCENERGY (K201188, 30 September 2020) and Philips' PercuNav image fusion and navigation (K201053, 14 May 2020).

## Fields

- Kind: Technology
- Status: emerging
- Last checked: 2026-11-04
- Also known as: Needle insertion robot; CT-guided robot; Percutaneous navigation; XACT ACE; Epione; MICROMATE; CAS-One IR; IMACTIS CT-Navigation; SCENERGY; PercuNav
- Tags: devices-gaps-2026-11
- Principle: A CT dataset defines the target and entry point; a robot arm or patient-mounted device aligns a needle guide to the planned trajectory, with optical or electromagnetic tracking and repeat CT to confirm the tip position.
- Since: 2018
- Strengths: Planned trajectories to small or deep targets; May reduce needle repositioning and repeat scans
- Limitations: Outcome advantage over freehand CT guidance not established here; Capital cost and set-up time

## Sources

- FDA 510(k) K221116: XACT ACE robotic system (13 May 2022): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221116
- FDA 510(k) K211645: Epione (24 February 2022): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211645
- FDA 510(k) K203720: MICROMATE (22 June 2021): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203720
- FDA 510(k) K232022: CAS-One IR (13 March 2024): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232022
- FDA 510(k) K162314: IMACTIS CT-Navigation (24 April 2018): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162314
- FDA 510(k) K201188: Clear Guide SCENERGY (30 September 2020): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201188
- FDA 510(k) K201053: PercuNav (14 May 2020): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201053

## Connected records

- cancers: [Hepatocellular carcinoma](https://onco.cc/cancers/hcc/)
- fronts: [Devices & Physical Therapies](https://onco.cc/fronts/devices/), [Imaging](https://onco.cc/fronts/imaging/), [Surgery & Interventional](https://onco.cc/fronts/surgery/)
- technologies: [Cryoablation systems](https://onco.cc/technologies/cryoablation-systems/), [CT (computed tomography)](https://onco.cc/technologies/ct/), [Microwave and radiofrequency ablation systems](https://onco.cc/technologies/microwave-rf-ablation/), [MRI-ultrasound fusion prostate biopsy systems (UroNav, Artemis, KOELIS Trinity, Mona Lisa)](https://onco.cc/technologies/prostate-fusion-biopsy-systems/), [Surgical robots: da Vinci, Hugo, Versius and single-port systems](https://onco.cc/technologies/surgical-robot-platforms/)
- companies: [Philips](https://onco.cc/companies/philips/), [Quantum Surgical](https://onco.cc/companies/quantum-surgical/), [XACT Robotics](https://onco.cc/companies/xact-robotics/)
- terms: [Core needle biopsy and fine-needle aspiration (FNA)](https://onco.cc/terms/core-needle-biopsy/)

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