Clearance Summary
GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X received FDA 510(k) clearance under submission number K032656, sponsored by Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2003-10-30.
- Submission: K032656
- Applicant / Sponsor: Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2003-10-30
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.