Clearance Summary
EAGLE EDGE AXR90 and AXR120 received FDA 510(k) clearance under submission number K210820, 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 2021-08-10.
- Submission: K210820
- 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: 2021-08-10
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.