A battery-powered, hand-held device/device assembly designed to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addition
| Company | Devices | Share |
|---|---|---|
| Clarius Mobile Health Corp | 38 | 22% |
| Butterfly Network, Inc. | 21 | 12% |
| Teratech Corporation | 20 | 12% |
| Fcu | 15 | 9% |
| Leltek Inc. | 14 | 8% |
| Echonous, Inc. | 12 | 7% |
| Guangdong Youkey Medical Co., Ltd. | 7 | 4% |
| Aco Healthcare Co., Ltd. | 7 | 4% |
| Vave Health, Inc. | 5 | 3% |
| Biim Ultrasound As | 4 | 2% |
| Analogic Corporation | 4 | 2% |
| Pulsenmore Ltd | 3 | 2% |
Company = labeler of record on GUDID. 24 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 |
|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | 138 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 137 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 112 |
| ITX | Transducer, ultrasonic, diagnostic | 14 |
| IYO | System, imaging, pulsed echo, ultrasonic | 14 |
| IYN | System, imaging, pulsed doppler, ultrasonic | 13 |
Use these as the dimensions to specify in a tender line.
170 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Hand-held ultrasound imaging system, body-surface", from 24 companies. The largest labeler is Clarius Mobile Health Corp with 22% of records.
ITX (Transducer, Ultrasonic, Diagnostic), IYO (System, Imaging, Pulsed Echo, Ultrasonic), IYN (System, Imaging, Pulsed Doppler, Ultrasonic), ITX (Transducer, ultrasonic, diagnostic)
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.