SFV — X-Ray, Computed Tomography, Cone-Beam Class II
FDA product code SFV covers "X-Ray, Computed Tomography, Cone-Beam", a Class II medical device regulated under 21 CFR 892.1750. Submissions are reviewed by the Radiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SFV
- Device Class
- Class II
- Regulation Number
- 892.1750
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Definition
Cone-beam computed tomography produced cross-sectional diagnostic x-ray images of whole body except dental structures.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250318 | planmed | Planmed XFI | September 26, 2025 |