Data / Medical devices / China / Shantou Institute Of Ultrasonic Instruments Co., Ltd.
Shantou Institute Of Ultrasonic Instruments Co., Ltd.: FDA-registered device maker in Shantou Guangdong, China, 19 510(k) clearances
Shantou Institute Of Ultrasonic Instruments Co., Ltd. is registered with the FDA (registration 3017944270) in Shantou Guangdong, China. It lists 8 device types. The FDA files 19 510(k) clearances under its listings, the newest dated June 18, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3017944270
- Address
- 3 Longjiang Road, Shantou Guangdong, China, 515000
- Owner or operator
- SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. (9011618)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 2, 2007
- Registered through
- 2026
- Brand names listed
- Apogee 1000, Apogee 1000B/W, Apogee 1000Exp, Apogee 1000Lite, Apogee 1000Neo, Apogee 1100, Apogee 1200, Apogee 1G and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | 1 | Manufacturer | accessdata.fda.gov |
| Fluid Jet Removal System | PZP | 2 | Contract manufacturer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Mobile | IZL | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 18, 2026 | K253058 | Portable DR Imaging System | IZL | Substantially Equivalent | Shantou Institute of Ultrasonic Instruments Co., Ltd. | accessdata.fda.gov |
| March 31, 2025 | K243178 | Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di | IYN | Substantially Equivalent | Shantou Institute of Ultrasonic Instruments Co., Ltd. | accessdata.fda.gov |
| December 10, 2024 | K243132 | Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) | IYN | Substantially Equivalent | Shantou Institute of Ultrasonic Instruments Co., Ltd. | accessdata.fda.gov |
| August 19, 2021 | 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 | Substantially Equivalent | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | accessdata.fda.gov |
| August 18, 2021 | K210318 | Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System | IYN | Substantially Equivalent | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | accessdata.fda.gov |
| January 6, 2021 | K202350 | SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System | IZL | Substantially Equivalent | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | accessdata.fda.gov |
| December 23, 2020 | K202353 | SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System | IZL | Substantially Equivalent | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | accessdata.fda.gov |
| July 9, 2020 | K200637 | SR-8100 Portable X-ray Unit | IZL | Substantially Equivalent | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | accessdata.fda.gov |
| June 10, 2020 | K200976 | SR-8230, SR-8230S Portable X-ray Unit | IZL | Substantially Equivalent | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | accessdata.fda.gov |
| December 7, 2017 | K173000 | Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System | IYN | Substantially Equivalent | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | accessdata.fda.gov |
| June 27, 2016 | K160853 | Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System | IYN | Substantially Equivalent | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | accessdata.fda.gov |
| June 15, 2012 | K113613 | DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM | IYN | Substantially Equivalent | Shantou Institute of Ultrasonic Instuments | accessdata.fda.gov |
| April 15, 2011 | K110841 | DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER | IYN | Substantially Equivalent | Shantou Institute of Ultrasonic Instruments (Siui | accessdata.fda.gov |
| October 19, 2010 | K102023 | DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C | IYN | Substantially Equivalent | Shantou Institute of Ultrasonic Instruments (Siui | accessdata.fda.gov |
| June 8, 2010 | K101008 | DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY | ITX | Substantially Equivalent | Shantou Institute of Ultrasonic Instruments (Siui | accessdata.fda.gov |
| March 5, 2010 | K092907 | DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR | IYN | Substantially Equivalent | Shantou Institute of Ultrasonic Instuments | accessdata.fda.gov |
| May 16, 2008 | K081110 | SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM | IYO | Substantially Equivalent | Shantou Institute of Ultrasonic Instuments | accessdata.fda.gov |
| May 2, 2007 | K070982 | CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM | IYO | Substantially Equivalent | Shantou Institute of Ultrasonic Instuments | accessdata.fda.gov |
| June 30, 2006 | K061488 | CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM | IYN | Substantially Equivalent | Shantou Institute of Ultrasonic Instruments (Siui | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of System, X-Ray, Mobile
- All makers of System, Image Processing, Radiological
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
Updated June 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.