Clearance Summary
OEC Elite MiniView received FDA 510(k) clearance under submission number K171800, sponsored by Ge Hualun Medical Systems Co. , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2017-07-12.
- Submission: K171800
- Applicant / Sponsor: Ge Hualun Medical Systems Co. , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2017-07-12
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.