Clearance Summary
U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000 received FDA 510(k) clearance under submission number K013848, 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 2002-04-08.
- Submission: K013848
- Applicant / Sponsor: U-Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2002-04-08
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.