Clearance Summary
SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System received FDA 510(k) clearance under submission number K163140, sponsored by Gemss 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 2017-05-26.
- Submission: K163140
- Applicant / Sponsor: Gemss Medical Systems Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2017-05-26
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.