510(k) · Cleared
ClearedPlanmed XFI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Planmed OY · SFV X-Ray, Computed Tomography, Cone-Beam
Cleared on Sep 26, 2025 as substantially equivalent to K220664 (Cefla S.C., 2022) after a 234-day review. Its family tree reaches back 2 generations to 2019.
- Decided
- Sep 26, 2025
- Review
- 234 days
- Class
- Class II
- Product code
- SFV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K183448 (2019). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SFV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K220664 | NewTom 7GSummary page 5…892.1750) Regulatory Class: II Product Code: JAK 510(K) # K220664 IV. DEVICE DESCRIPTION The Planmed XFI X-ray unit utilizes cone beam computed tomography (CBCT) to genera… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All SFV devicesSFV X-Ray, Computed Tomography, Cone-Beam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SFV
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SFV
Too few SFV 510(k)s in any year since 2007 to give a median.
Recalls per year · SFV
No recall names SFV since 2007.
Adverse event reports per year · SFV
No MAUDE report names SFV since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250318: Planmed XFI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250318
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026