Clearance Summary
GE DIASONICS GATEWAY AND GATEWAY FX received FDA 510(k) clearance under submission number K993069, sponsored by General Electric Co.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1999-09-22.
- Submission: K993069
- Applicant / Sponsor: General Electric Co.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1999-09-22
Classification & Regulation
This clearance is catalogued under FDA product code IYO and 21 CFR 892.1560, within the Radiology review panel as a Class II device.