# K250318: Planmed XFI

- Pathway: 510(k) (Traditional)
- Applicant: Planmed OY
- Decided: Sep 26, 2025 after 234 days
- Product code: SFV (X-Ray, Computed Tomography, Cone-Beam)
- 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: 2 generations back to K183448 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220664: NewTom 7G, Cefla S.C. (2022) Summary page 5.

## Indications for use
Planmed XFI is intended to be used for cone beam computed tomography imaging of anatomies within sections of the spine, of upper extremities including shoulder(s), hand, relative joints (shoulder(s), elbow, wrist) and of lower extremities including hip(s), foot and feet, and relative joints (hip(s), knee(s), ankle(s)). The device is to be managed and operated/used in a professional healthcare environment by healthcare professionals and other legally qualified professionals only.

Source page: https://510kreport.com/device/K250318
Methodology: https://510kreport.com/methodology