Clearance Summary
DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR received FDA 510(k) clearance under submission number K092907, sponsored by Shantou Institute of Ultrasonic Instuments. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2010-03-05.
- Submission: K092907
- Applicant / Sponsor: Shantou Institute of Ultrasonic Instuments
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2010-03-05
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.