Clearance Summary
AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS received FDA 510(k) clearance under submission number K052355, sponsored by U-Systems, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2005-09-14.
- Submission: K052355
- Applicant / Sponsor: U-Systems, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 2005-09-14
Classification & Regulation
This clearance is catalogued under FDA product code IYO and 21 CFR 892.1560, within the Radiology review panel as a Class II device.