Clearance Summary
MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND received FDA 510(k) clearance under submission number K092079, sponsored by Ge Medical Systems Israel, Ultrasound, 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 2009-08-06.
- Submission: K092079
- Applicant / Sponsor: Ge Medical Systems Israel, Ultrasound, Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2009-08-06
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.