Clearance Summary
XPLUS 35 Series (XPLUS 35, XPLUS 35FD) received FDA 510(k) clearance under submission number K233200, sponsored by GEMSS HEALTHCARE CO., 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 2023-11-16.
- Submission: K233200
- Applicant / Sponsor: GEMSS HEALTHCARE CO., LTD.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2023-11-16
Classification & Regulation
This clearance is catalogued under FDA product code OWB and 21 CFR 892.1650, within the Radiology review panel as a Class II device.