Clearance Summary
GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2 received FDA 510(k) clearance under submission number K082185, sponsored by Ge Medical Systems Ultrasound and Primary Care Dia. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2008-08-15.
- Submission: K082185
- Applicant / Sponsor: Ge Medical Systems Ultrasound and Primary Care Dia
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 2008-08-15
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.