Clearance Summary
Optima XR646 received FDA 510(k) clearance under submission number K143270, 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 2015-02-18.
- Submission: K143270
- Applicant / Sponsor: Ge Hualun Medical Systems Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2015-02-18
Classification & Regulation
This clearance is catalogued under FDA product code KPR and 21 CFR 892.1680, within the Radiology review panel as a Class II device.