Clearance Summary
Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) received FDA 510(k) clearance under submission number K243132, sponsored by Shantou Institute of Ultrasonic Instruments Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2024-12-10.
- Submission: K243132
- Applicant / Sponsor: Shantou Institute of Ultrasonic Instruments Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2024-12-10
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.