Product Code: SFV
FDA class 2
21 CFR 892.1750
X-Ray, Computed Tomography, Cone-Beam
Radiology
510(k)s
1
FEI Numbers
2
Registration Numbers
2
Unique Applicants
1
Years Active
—
Basic Information
- Product Code
- SFV
- Device Class
- FDA class 2
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
Cone-beam computed tomography produced cross-sectional diagnostic x-ray images of whole body except dental structures.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250318 | Planmed XFI | Sep 26, 2025 | Substantially Equivalent | Planmed OY |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.