510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250318Substantially Equivalent

Planmed XFI

Planmed Oy, Helsinki, FI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250318 is the FDA 510(k) clearance record for Planmed XFI, a class II device, cleared for Planmed OY on under FDA product code SFV (X-Ray, Computed Tomography, Cone-Beam). FDA's definition for product code SFV reads: "Cone-beam computed tomography produced cross-sectional diagnostic x-ray images of whole body except dental structures". FDA records list 20 510(k) clearances for Planmed OY, from to . As of , FDA records show no recalls naming K250318.

Clearance record

Decision date
Received
(234 days to decision)
Product code
SFV X-Ray, Computed Tomography, Cone-Beam
Regulation
21 CFR 892.1750
Device class
Class II
Review panel
Radiology
Applicant
Planmed OY Sorvaajankatu 7, Helsinki, FI
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code SFV

Trailing 12 months

FDA records hold no clearances under product code SFV in the trailing twelve months.

FDA records show no clearances under product code SFV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SFV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260