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Device Explorer · FDA GUDID · GMDN 40935

Diagnostic x-ray digital imaging system workstation

A freestanding component of an x-ray-based diagnostic digital imaging assembly [e.g., a digital x-ray system, x-ray computed tomography (CT) system, or fluoroscopy system] designed to process patient radiological images; it may additionally be intended to be i

US‑registered devices82in commercial distribution
Companies21labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription74%Rx‑only share
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Share of device records

Nuvasive, Inc.3745%
Image Diagnostics, Inc.1518%
Cathworks Ltd34%
Konica Minolta Medical Imaging U.S.A., Inc.34%
Villa Sistemi Medicali Spa34%
Siemens Healthcare Gmbh22%
Ortho Kinematics, Inc.22%
Driving Force Company22%

Top labelers

CompanyDevicesShare
Nuvasive, Inc.3745%
Image Diagnostics, Inc.1518%
Cathworks Ltd34%
Konica Minolta Medical Imaging U.S.A., Inc.34%
Villa Sistemi Medicali Spa34%
Siemens Healthcare Gmbh22%
Ortho Kinematics, Inc.22%
Driving Force Company22%
Ge Medical Systems22%
Micronica Srl22%
Vuze Medical Ltd11%
Fujifilm Corporation11%

Company = labeler of record on GUDID. 21 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

VUZE System 2.0FFRangioFCRViewsyngo X WorkplaceLessRayVMA Motion NormalizerVMAX1-FFRDel Medical, Inc.coDiagnostiXIMAGE DIAGNOSTICS, INC.IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INCTrackXSenoIrisNA

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

FDA product codes

CodeNameDevices
LLZSystem, image processing, radiological42
OWBInterventional fluoroscopic x-ray system35
JAASystem, x-ray, fluoroscopic, image-intensified35
LMDSystem, Digital Image Communications, Radiological16
LLZSystem, Image Processing, Radiological14
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)7

GMDN & GCC registration

  • GMDN code 40935 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 74% · 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

No structured size data on the register.

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

How many diagnostic x-ray digital imaging system workstation products are registered in the US?

82 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Diagnostic x-ray digital imaging system workstation", from 21 companies. The largest labeler is Nuvasive, Inc. with 45% of records.

Which FDA product codes apply?

LLZ (System, image processing, radiological), OWB (Interventional fluoroscopic x-ray system), JAA (System, x-ray, fluoroscopic, image-intensified), LMD (System, Digital Image Communications, Radiological)

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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