An assembly of mains electricity (AC-powered) devices designed for ophthalmic imaging procedures. It includes software that supports a variety of static and real-time eye and orbital imaging applications including physical measurement and oncology related trea
| Company | Devices | Share |
|---|---|---|
| Sonomed, Inc. | 22 | 28% |
| Accutome, Inc. | 16 | 21% |
| Ellex Medical Pty Ltd | 8 | 10% |
| Quantel Medical | 7 | 9% |
| Chongqing Sunkingdom Medical Instrument Co.,Ltd | 6 | 8% |
| Meda Co., Ltd | 5 | 6% |
| Nidek Co.,Ltd. | 5 | 6% |
| U.S. Ophthalmic, L.L.C. | 4 | 5% |
| Arcscan, Inc. | 2 | 3% |
| Dgh Technology Inc. | 1 | 1% |
| Micro Medical Devices, Inc. | 1 | 1% |
| Lightmed Usa Inc | 1 | 1% |
Company = labeler of record on GUDID. 12 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 |
|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 75 |
| ITX | Transducer, Ultrasonic, Diagnostic | 45 |
| IYX | Camera, Scintillation (Gamma) | 2 |
Use these as the dimensions to specify in a tender line.
78 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ophthalmic ultrasound imaging system", from 12 companies. The largest labeler is Sonomed, Inc. with 28% of records.
IYO (System, Imaging, Pulsed Echo, Ultrasonic), ITX (Transducer, Ultrasonic, Diagnostic), IYX (Camera, Scintillation (Gamma))
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.