Clearance Summary
ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT received FDA 510(k) clearance under submission number K042619, sponsored by Sonotech, 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 2004-11-05.
- Submission: K042619
- Applicant / Sponsor: Sonotech, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 2004-11-05
Classification & Regulation
This clearance is catalogued under FDA product code MUI and 21 CFR 892.1570, within the Radiology review panel as a Class II device.