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510(k) K250318

Planmed XFI by Planmed OY — Product Code SFV

K250318 is an FDA 510(k) premarket notification submitted by Planmed OY for the device "Planmed XFI". The FDA issued a decision of Substantially Equivalent on September 26, 2025. The device falls under product code SFV (X-Ray, Computed Tomography, Cone-Beam), a Class II device regulated under 21 CFR 892.1750. Planmed OY has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2025
Date Received
February 4, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
X-Ray, Computed Tomography, Cone-Beam
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

Cone-beam computed tomography produced cross-sectional diagnostic x-ray images of whole body except dental structures.

Other clearances by Planmed OY

  • K211720 — Planmed Clarity 2D, Planmed Clarify S (July 18, 2022)
  • K213278 — Planmed Verity (April 28, 2022)
  • K192317 — Planmed Clarity 2D and Clarity S (October 23, 2020)
  • K180918 — Planmed Verity (November 30, 2018)
  • K163328 — Planmed Clarity (December 28, 2017)
  • K143435 — Planmed Verity (May 14, 2015)
  • K121418 — PLANMED VERITY (February 1, 2013)
  • K121963 — PLANMED NUANCE DIGIGUIDE (November 21, 2012)
  • K042671 — PLANMED SOPHIE NUANCE CLASSIC (November 19, 2004)
  • K021945 — PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE) (February 21, 2003)

FDA data resources