SFV
- Product code
- SFV
- Device name
- X-Ray, Computed Tomography, Cone-Beam
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.1750
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
FDA classification definition
Cone-beam computed tomography produced cross-sectional diagnostic x-ray images of whole body except dental structures.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250318 | 2025-09-26 | Planmed OY | Planmed XFI |
Official FDA classification page: SFV
Classification and pathway per current FDA publications. Data from openFDA (CC0).