{"entity":{"id":"image-guided-percutaneous-robots","kind":"technology","name":"CT-guided needle robots and percutaneous navigation (XACT ACE, Epione, MICROMATE, CAS-One IR)","aka":["Needle insertion robot","CT-guided robot","Percutaneous navigation","XACT ACE","Epione","MICROMATE","CAS-One IR","IMACTIS CT-Navigation","SCENERGY","PercuNav"],"tldr":"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).","status":"emerging","asOf":"2026-11-04","links":[{"label":"FDA 510(k) K221116: XACT ACE robotic system (13 May 2022)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221116"},{"label":"FDA 510(k) K211645: Epione (24 February 2022)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211645"},{"label":"FDA 510(k) K203720: MICROMATE (22 June 2021)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203720"},{"label":"FDA 510(k) K232022: CAS-One IR (13 March 2024)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232022"},{"label":"FDA 510(k) K162314: IMACTIS CT-Navigation (24 April 2018)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162314"},{"label":"FDA 510(k) K201188: Clear Guide SCENERGY (30 September 2020)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201188"},{"label":"FDA 510(k) K201053: PercuNav (14 May 2020)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201053"}],"tags":["devices-gaps-2026-11"],"related":[],"cancers":["hcc"],"sections":["imaging","surgery","devices"],"technologies":["ct","microwave-rf-ablation","cryoablation-systems","surgical-robot-platforms"],"targets":[],"drugs":[],"companies":["xact-robotics","quantum-surgical","philips"],"institutions":[],"pathways":[],"terms":["core-needle-biopsy"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo device gap fill (openFDA, accessdata.fda.gov, NICE, Europe PMC, maker pages)","editedOn":"2026-11-04"},"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.","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"],"since":2018},"route":"/technologies/image-guided-percutaneous-robots/","neighbours":{"cancer":[{"id":"hcc","kind":"cancer","name":"Hepatocellular carcinoma","route":"/cancers/hcc/"}],"section":[{"id":"devices","kind":"section","name":"Devices & Physical Therapies","route":"/fronts/devices/"},{"id":"imaging","kind":"section","name":"Imaging","route":"/fronts/imaging/"},{"id":"surgery","kind":"section","name":"Surgery & Interventional","route":"/fronts/surgery/"}],"technology":[{"id":"cryoablation-systems","kind":"technology","name":"Cryoablation systems","route":"/technologies/cryoablation-systems/"},{"id":"ct","kind":"technology","name":"CT (computed tomography)","route":"/technologies/ct/"},{"id":"microwave-rf-ablation","kind":"technology","name":"Microwave and radiofrequency ablation systems","route":"/technologies/microwave-rf-ablation/"},{"id":"prostate-fusion-biopsy-systems","kind":"technology","name":"MRI-ultrasound fusion prostate biopsy systems (UroNav, Artemis, KOELIS Trinity, Mona Lisa)","route":"/technologies/prostate-fusion-biopsy-systems/"},{"id":"surgical-robot-platforms","kind":"technology","name":"Surgical robots: da Vinci, Hugo, Versius and single-port systems","route":"/technologies/surgical-robot-platforms/"}],"company":[{"id":"philips","kind":"company","name":"Philips","route":"/companies/philips/"},{"id":"quantum-surgical","kind":"company","name":"Quantum Surgical","route":"/companies/quantum-surgical/"},{"id":"xact-robotics","kind":"company","name":"XACT Robotics","route":"/companies/xact-robotics/"}],"term":[{"id":"core-needle-biopsy","kind":"term","name":"Core needle biopsy and fine-needle aspiration (FNA)","route":"/terms/core-needle-biopsy/"}]}}