Clearance Summary
SonoSite Edge II Ultrasound System received FDA 510(k) clearance under submission number K153626, sponsored by FUJIFILM Sonosite, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2016-01-20.
- Submission: K153626
- Applicant / Sponsor: FUJIFILM Sonosite, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2016-01-20
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.