Clearance Summary
LOGIQ E9, LOGIQ E9 XDClear 2.0 received FDA 510(k) clearance under submission number K163077, sponsored by GE Medical Systems Ultrasound and Primary Care Diagnostics. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2016-11-17.
- Submission: K163077
- Applicant / Sponsor: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2016-11-17
Classification & Regulation
This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.