A dedicated computerized radiology information system (RIS) designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clin
| Company | Devices | Share |
|---|---|---|
| Pentax Of America, Inc. | 108 | 89% |
| Ramsoft Inc | 5 | 4% |
| Ambra Health | 3 | 2% |
| Orpheus Medical Ltd | 2 | 2% |
| Avreo Inc | 2 | 2% |
| Radlink, Inc. | 1 | 1% |
Company = labeler of record on GUDID. 6 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 |
|---|---|---|
| OUG | Medical Device Data System | 109 |
| LLZ | System, Image Processing, Radiological | 9 |
| LMD | System, Digital Image Communications, Radiological | 3 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 1 |
Use these as the dimensions to specify in a tender line.
121 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Radiology information system", from 6 companies. The largest labeler is Pentax Of America, Inc. with 89% of records.
OUG (Medical Device Data System), LLZ (System, Image Processing, Radiological), LMD (System, Digital Image Communications, Radiological), MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
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.