The cone-beam computed tomography system can image patients in standing, seated, or supine positions.
The US Food and Drug Administration has issued 510(k) clearance for the Planmed XFI, a full-body cone-beam computed tomography (CT) system designed to scan patients in standing, seated, and supine positions. The clearance was granted on September 26, 2025.
Developed by Finnish medical imaging company Planmed, the system allows for imaging the entire body under a natural load. This capability is intended to help clinicians detect subtle fractures, misalignments, and other conditions that may not be apparent when a patient is lying down, offering an alternative to conventional 2D radiographs. The scanner provides 3D imaging at the point of care for both pre- and postoperative evaluations.
“Planmed XFI is the first and only full-body CT system in the world that can image seated, supine, and standing patients,” says Jan Moed, managing director of Planmed Oy, in a release. “We are excited that this innovative, low-dose orthopedic imaging system is now available in the US. We are confident that it will be well received.”
The company’s US subsidiary, Planmed USA, Inc, located in Charlotte, NC, will manage sales, marketing, and technical support for the system in North America.
“We are very pleased to expand our CT imaging equipment line. Many of our customers have been looking forward to this clearance,” Moed adds in the release.
The Planmed XFI was displayed at the RSNA Annual Meeting in Chicago.
