Clearance Summary
MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS received FDA 510(k) clearance under submission number K080930, sponsored by U-System, 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 2008-08-07.
- Submission: K080930
- Applicant / Sponsor: U-System, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 2008-08-07
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.