FDA 510(k) Applications Submitted by Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI)

FDA 510(k) Number Submission Date Device Name Applicant
K210317 02/03/2021 Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI)
K210318 02/03/2021 Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI)
K200637 03/10/2020 SR-8100 Portable X-ray Unit Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI)
K200976 04/13/2020 SR-8230, SR-8230S Portable X-ray Unit Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI)
K202350 08/18/2020 SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI)
K202353 08/18/2020 SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI)
K173000 09/27/2017 Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI)


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