FDA 510(k) Applications Submitted by FLOWER CAI
| 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) |
| K110841 |
03/25/2011 |
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER |
SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI |
| K160853 |
03/28/2016 |
Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System |
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) |
| K113613 |
12/06/2011 |
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM |
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
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