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.
1
Total
1
Cleared
234d
Avg days
2025
Since
Growing category -
1 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)
1 devices
About Product Code SFV - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SFV since 2025, with 1 receiving FDA clearance (average review time: 234 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SFV devices are reviewed by the Radiology panel. Browse all Radiology devices →