SFV · X-Ray, Computed Tomography, Cone-Beam
Radiology · 21 CFR 892.1750 · Class 2
Overview
| Product Code | SFV |
|---|---|
| Device Name | X-Ray, Computed Tomography, Cone-Beam |
| Regulation | 21 CFR 892.1750 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250318 | Planmed XFI | Planmed OY | Sep 26, 2025 | SESE |
Top Applicants
- Planmed OY — 1 clearance
