Clearance Summary
KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS received FDA 510(k) clearance under submission number K060671, sponsored by Wfr/Aquaplast Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2006-05-04.
- Submission: K060671
- Applicant / Sponsor: Wfr/Aquaplast Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5770
- Decision date: 2006-05-04
Classification & Regulation
This clearance is catalogued under FDA product code JAI and 21 CFR 892.5770, within the Radiology review panel as a Class II device.