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Device Explorer · FDA GUDID · GMDN 37646

Mobile general-purpose fluoroscopic x-ray system, digital

A mobile (within an imaging facility) general-purpose diagnostic fluoroscopic x-ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is designed to be used in a variety of general-purpose applications requiring re

US‑registered devices95in commercial distribution
Companies16labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription76%Rx‑only share
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Share of device records

A.T.S. Applicazione Tecnologie Speciali Srl2931%
Fujifilm Corporation1112%
Philips Medical Systems Nederland B.V.88%
Ge Hualun Medical Systems Co., Ltd88%
Genoray Co., Ltd.77%
Ziehm Imaging Gmbh55%
Oec Medical Systems, Inc.44%
Gemss Medical Systems Co.,Ltd.44%

Top labelers

CompanyDevicesShare
A.T.S. Applicazione Tecnologie Speciali Srl2931%
Fujifilm Corporation1112%
Philips Medical Systems Nederland B.V.88%
Ge Hualun Medical Systems Co., Ltd88%
Genoray Co., Ltd.77%
Ziehm Imaging Gmbh55%
Oec Medical Systems, Inc.44%
Gemss Medical Systems Co.,Ltd.44%
Ecotron44%
Beijing East Whale Imaging Technology Co.,Ltd.33%
Turner Imaging Systems33%
Drtech Corporation33%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

WHALEFDR CROSS SlimWired foot switchMonitor cartWireless foot switch kitFlat panel sensor holderGrid (17x17)Grid (14x17)Grid (10x12)FDR CROSSZenition 90Zenition 30ZenitionVeradiusBV PulseraBV Endura

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
OWBInterventional Fluoroscopic X-Ray System80
OXOImage-Intensified Fluoroscopic X-Ray System, Mobile69
JAASystem, X-Ray, Fluoroscopic, Image-Intensified56
JAASystem, x-ray, fluoroscopic, image-intensified11
OXOImage-intensified fluoroscopic x-ray system, mobile11
JAKSystem, X-Ray, Tomography, Computed8

GMDN & GCC registration

  • GMDN code 37646 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 76% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Kilogram) · 8Height (Millimeter) · 8Width (Millimeter) · 8Length (Millimeter) · 8

Use these as the dimensions to specify in a tender line.

How many mobile general-purpose fluoroscopic x-ray system, digital products are registered in the US?

95 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Mobile general-purpose fluoroscopic x-ray system, digital", from 16 companies. The largest labeler is A.T.S. Applicazione Tecnologie Speciali Srl with 31% of records.

Which FDA product codes apply?

OWB (Interventional Fluoroscopic X-Ray System), OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile), JAA (System, X-Ray, Fluoroscopic, Image-Intensified), JAA (System, x-ray, fluoroscopic, image-intensified)

Is this the same as UAE/GCC registration?

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.

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