FDA product code SFV: X-Ray, Computed Tomography, Cone-Beam
SFV is the FDA product code for x-ray, computed tomography, cone-beam. It is a Class II device, regulated under 21 CFR 892.1750 and reviewed by the Radiology panel. FDA has cleared 1 510(k) submission under SFV, 1 in the last five years. The average 510(k) review took 234 days (median 234); 234 days on average over the last three years.
Definition
Cone-beam computed tomography produced cross-sectional diagnostic x-ray images of whole body except dental structures.
Classification
| Field | Value |
|---|---|
| Device name | X-Ray, Computed Tomography, Cone-Beam |
| Device class | Class II |
| Regulation | 21 CFR 892.1750 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for SFV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 234 |
Compare with all 510(k) review times · Search every SFV clearance
Top SFV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Planmed OY | 1 | 2025-09-26 |
Most recent SFV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250318 | Planmed OY | Planmed XFI | 2025-09-26 | 234 |
Recalls for SFV devices
openFDA lists no recalls for product code SFV.
Frequently asked questions
What is FDA product code SFV?
SFV is the FDA product code for x-ray, computed tomography, cone-beam. It is a Class II device, regulated under 21 CFR 892.1750 and reviewed by the Radiology panel.
What device class is SFV?
Class II, regulation 21 CFR 892.1750. Typical premarket route: 510(k).
How long does a 510(k) take for product code SFV?
Across 1 cleared submissions the average was 234 days from receipt to decision (median 234).
Which companies have the most SFV clearances?
Planmed OY (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SFV
- Run a recall and safety report across every SFV manufacturer
- Watch product code SFV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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