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Device Explorer · FDA GUDID · GMDN 37679

Stationary general-purpose fluoroscopic x-ray system, digital

A stationary general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoro

US‑registered devices81in commercial distribution
Companies19labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription47%Rx‑only share
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Share of device records

Shimadzu Corporation2227%
Guangdong Optomedic Technologies, Inc.911%
Stephanix810%
Amnotec International Medical Gmbh79%
Philips Medical Systems Dmc Gmbh67%
General Medical Merate Spa67%
Siemens Healthcare Gmbh56%
Canon Inc.34%

Top labelers

CompanyDevicesShare
Shimadzu Corporation2227%
Guangdong Optomedic Technologies, Inc.911%
Stephanix810%
Amnotec International Medical Gmbh79%
Philips Medical Systems Dmc Gmbh67%
General Medical Merate Spa67%
Siemens Healthcare Gmbh56%
Canon Inc.34%
C.M.T. Medical Technologies Ltd.22%
Del Medical, Inc.22%
Ge Medical Systems, L.L.C.22%
Villa Sistemi Medicali Spa22%

Company = labeler of record on GUDID. 19 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ArtPIX DRFDuet DRFFloNavi Light SourceImage Processing UnitFloNavi Camera HeadAMNOTECVEQTRONLight SourceAdora DRFiDR 800MULTIPURPOSE REMOTE CONTROL R/F SYSTEMCANON INC.FLUOROspeedSONIALVISION G4SONIALVISON G4LUMINOS Q.namix T

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

FDA product codes

CodeNameDevices
JAASystem, X-Ray, Fluoroscopic, Image-Intensified46
IZISystem, X-Ray, Angiographic22
GCJLaparoscope, General & Plastic Surgery19
OWBInterventional Fluoroscopic X-Ray System11
JAASystem, x-ray, fluoroscopic, image-intensified10
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)6

GMDN & GCC registration

  • GMDN code 37679 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 47% · 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) · 1

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

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

81 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Stationary general-purpose fluoroscopic x-ray system, digital", from 19 companies. The largest labeler is Shimadzu Corporation with 27% of records.

Which FDA product codes apply?

JAA (System, X-Ray, Fluoroscopic, Image-Intensified), IZI (System, X-Ray, Angiographic), GCJ (Laparoscope, General & Plastic Surgery), OWB (Interventional Fluoroscopic X-Ray System)

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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