An assembly of devices that are part of a fluoroscopic x-ray system and specifically designed to display x-ray images in real-time. It is often referred to as an x-ray imaging chain. It includes a video camera [charge-coupled device (CCD) or tube based], a vid
| Company | Devices | Share |
|---|---|---|
| Nical Spa | 93 | 99% |
| Direx Systems Corp. | 1 | 1% |
Company = labeler of record on GUDID. 2 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 |
|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 94 |
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94 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Fluoroscopic x-ray system video image recording unit", from 2 companies. The largest labeler is Nical Spa with 99% of records.
JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
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.