Clearance Summary
Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph received FDA 510(k) clearance under submission number K213579, sponsored by Fona S.R.L. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2022-03-02.
- Submission: K213579
- Applicant / Sponsor: Fona S.R.L
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2022-03-02
Classification & Regulation
This clearance is catalogued under FDA product code OAS and 21 CFR 892.1750, within the Radiology review panel as a Class II device.