Clearance Summary
Discovery XR656 HD received FDA 510(k) clearance under submission number K172869, 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 2017-10-20.
- Submission: K172869
- Applicant / Sponsor: Ge Hualun Medical Systems Co. , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2017-10-20
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.