Clearance Summary
UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance under submission number K081919, sponsored by Fukuda Denshi Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2008-09-09.
- Submission: K081919
- Applicant / Sponsor: Fukuda Denshi Co., Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 2008-09-09
Classification & Regulation
This clearance is catalogued under FDA product code ITX and 21 CFR 892.1570, within the Radiology review panel as a Class II device.