Clearance Summary
Dental CT Scanner AXR received FDA 510(k) clearance under submission number K223816, sponsored by Alliage S/A Industrias Medico Odontológica. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2023-04-07.
- Submission: K223816
- Applicant / Sponsor: Alliage S/A Industrias Medico Odontológica
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2023-04-07
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.