DeviceClearance

Product code SFV— Radiology

Planmed XFI

Classification name
X-Ray, Computed Tomography, Cone-Beam
Device class
Class 2
Regulation
21 CFR 892.1750
Advisory panel
Radiology
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code SFV under 21 CFR 892.1750, via openFDA

Market context for product code SFV

FDA has cleared 1 device under product code SFV, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SFV

Recent clearances under product code SFV

Data sourced from openFDA. This site is unofficial and independent of the FDA.