Clearance Summary
U-SYSTEMS ULTRASOUND SYSTEM USI-2000 received FDA 510(k) clearance under submission number K003479, sponsored by U-Systems, 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 2001-01-18.
- Submission: K003479
- Applicant / Sponsor: U-Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2001-01-18
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.