Clearance Summary
Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System received FDA 510(k) clearance under submission number K160853, sponsored by Shantou Institute of Ultrasonic Instruments Co., Ltd. (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 2016-06-27.
- Submission: K160853
- Applicant / Sponsor: Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2016-06-27
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.