Clearance Summary
AXXENT RADIATION SHIELD - RIGID received FDA 510(k) clearance under submission number K111299, sponsored by Xoft, an Icad Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2011-07-20.
- Submission: K111299
- Applicant / Sponsor: Xoft, an Icad Company
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5900
- Decision date: 2011-07-20
Classification & Regulation
This clearance is catalogued under FDA product code JAD and 21 CFR 892.5900, within the Radiology review panel as a Class II device.