Clearance Summary
XVI R4.5 received FDA 510(k) clearance under submission number K100115, sponsored by Elekta , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2010-03-10.
- Submission: K100115
- Applicant / Sponsor: Elekta , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2010-03-10
Classification & Regulation
This clearance is catalogued under FDA product code IYE and 21 CFR 892.5050, within the Radiology review panel as a Class II device.