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Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories2
Latest Approval2021-08-19
TypeNumberDevice NameCodeDate
510(k) K210317 Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System IYN 2021-08-19 View
510(k) K210318 Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System IYN 2021-08-18 View
510(k) K202350 SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System IZL 2021-01-06 View
510(k) K202353 SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System IZL 2020-12-23 View
510(k) K200637 SR-8100 Portable X-ray Unit IZL 2020-07-09 View
510(k) K200976 SR-8230, SR-8230S Portable X-ray Unit IZL 2020-06-10 View
510(k) K173000 Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System IYN 2017-12-07 View
510(k) K160853 Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System IYN 2016-06-27 View