FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph
K Number: K213579
·
Decision Mar 2, 2022
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
133
Applicant Total
4
Review Days
112
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Basic Information
- Device Name
- Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph
- K Number
- K213579
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fona S.R.L
- Date Received
- November 10, 2021
- Decision Date
- March 2, 2022
- Product Code
- OAS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | FDA class 2 | Radiology |
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