Clearance Summary
LV Liberty Vision Model 1 90Yttrium Brachytherapy Source received FDA 510(k) clearance under submission number K193602, sponsored by Lv Liberty Vision Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-05-29.
- Submission: K193602
- Applicant / Sponsor: Lv Liberty Vision Corporation
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5730
- Decision date: 2020-05-29
Classification & Regulation
This clearance is catalogued under FDA product code KXK and 21 CFR 892.5730, within the Radiology review panel as a Class II device.