Clearance Summary
SCANORA 3D received FDA 510(k) clearance under submission number K110839, sponsored by Soredex Palodex Group OY. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2011-06-30.
- Submission: K110839
- Applicant / Sponsor: Soredex Palodex Group OY
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2011-06-30
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.