Clearance Summary
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY received FDA 510(k) clearance under submission number K101008, sponsored by Shantou Institute of Ultrasonic Instruments (Siui. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2010-06-08.
- Submission: K101008
- Applicant / Sponsor: Shantou Institute of Ultrasonic Instruments (Siui
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 2010-06-08
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.