Clearance Summary
UROLIX-3 UROLOGICAL TABLE received FDA 510(k) clearance under submission number K840227, sponsored by Medicor USA , 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 1984-03-23.
- Submission: K840227
- Applicant / Sponsor: Medicor USA , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1984-03-23
Classification & Regulation
This clearance is catalogued under FDA product code IXR and 21 CFR 892.1980, within the Radiology review panel as a Class II device.