Planmed

Planmed Oy · Model XFI · UDI-DI 06430035430130

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Planmed XFI X-ray unit utilizes cone beam computed tomography (CBCT) to generate three dimensional images. In CBCT imaging, a cylindrical volume of data is acquired in a single imaging procedure. This data comprises several hundred 2D images taken from various angles to encompass a specific pre-programmed target area. These images are subsequently employed for 3D reconstruction, accomplished through a dedicated PC equipped with reconstruction algorithms. The resulting reconstructed images can be visualized in three dimensions using a separate PC workstation equipped with suitable image viewer software.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.