A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GY
| Company | Devices | Share |
|---|---|---|
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 445 | 16% |
| Samsung Medison Co., Ltd. | 367 | 13% |
| Fujifilm Sonosite, Inc. | 345 | 13% |
| Philips Ultrasound Llc | 213 | 8% |
| Qingdao Hisense Medical Co., Ltd. | 187 | 7% |
| Sonoscape Medical Corp. | 160 | 6% |
| Medisono, Llc | 116 | 4% |
| Ge Ultrasound Korea Ltd. | 101 | 4% |
| Shantou Institute Of Ultrasonic Instruments Co., Ltd. | 60 | 2% |
| Bard Access Systems, Inc. | 57 | 2% |
| Qingdao Hisense Medical Equipment Co., Ltd. | 56 | 2% |
| Edan Instruments, Inc. | 50 | 2% |
Company = labeler of record on GUDID. 68 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1,959 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1,626 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1,477 |
| IYN | System, imaging, pulsed doppler, ultrasonic | 683 |
| ITX | Transducer, ultrasonic, diagnostic | 641 |
| IYO | System, imaging, pulsed echo, ultrasonic | 639 |
Use these as the dimensions to specify in a tender line.
2,744 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General-purpose ultrasound imaging system", from 68 companies. The largest labeler is Shenzhen Mindray Bio-Medical Electronics Co., Ltd. with 16% of records.
IYN (System, Imaging, Pulsed Doppler, Ultrasonic), IYO (System, Imaging, Pulsed Echo, Ultrasonic), ITX (Transducer, Ultrasonic, Diagnostic), IYN (System, imaging, pulsed doppler, ultrasonic)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.