FDA Product Code SFV: X-ray, Computed Tomography, Cone-beam
Cone-beam Computed Tomography Produced Cross-sectional Diagnostic X-ray Images Of Whole Body Except Dental Structures.
Leading manufacturers include Planmed OY and Linatech, LLC.
2
Total
2
Cleared
239d
Avg days
2025
Since
Growing category -
2 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared X-ray, Computed Tomography, Cone-beam Devices (Product Code SFV)
2 devices
Cleared
Oct 19, 2026
VenusCT
Linatech, LLC
Radiology
244d
Cleared
Sep 26, 2025
Planmed XFI
Planmed OY
Radiology
234d
About Product Code SFV - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code SFV since 2025, with 2 receiving FDA clearance (average review time: 239 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.