SFV

X-Ray, Computed Tomography, Cone-Beam

Product code
SFV
Device name
X-Ray, Computed Tomography, Cone-Beam
Device class
Class 2
21 CFR
21 CFR 892.1750
Medical specialty
Radiology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
1 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-09-26.

NumberDecision dateApplicantDevice nameSummary
K2503182025-09-26Planmed OYPlanmed XFIPDF

1 summaries are archived here for direct download.

Official FDA classification page: SFV
Classification and pathway per current FDA publications. Data from openFDA (CC0).