Clearance Summary
OEC One received FDA 510(k) clearance under submission number K182626, sponsored by Ge Hualun Medical Systems 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 2018-11-16.
- Submission: K182626
- Applicant / Sponsor: Ge Hualun Medical Systems Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2018-11-16
Classification & Regulation
This clearance is catalogued under FDA product code OXO and 21 CFR 892.1650, within the Radiology review panel as a Class II device.