Clearance Summary
VIVID I DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance under submission number K102388, sponsored by Ge Medical System Israel , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2010-11-04.
- Submission: K102388
- Applicant / Sponsor: Ge Medical System Israel , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2010-11-04
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.