Clearance Summary
Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System received FDA 510(k) clearance under submission number K210317, 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 2021-08-19.
- Submission: K210317
- 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: 2021-08-19
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.