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Device Explorer · FDA GUDID · GMDN 37647

Mobile basic diagnostic x-ray system, digital

An assembly of devices that comprise a digital general-purpose mobile diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation and the mobile design allows it

US‑registered devices123in commercial distribution
Companies20labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription83%Rx‑only share
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Share of device records

Sedecal3730%
Minxray, Inc.1915%
Shimadzu Corporation119%
Drgem Corporation87%
Fujifilm Corporation76%
Ge Medical Systems, L.L.C.65%
Carestream Health, Inc.65%
Siemens Healthcare Gmbh54%

Top labelers

CompanyDevicesShare
Sedecal3730%
Minxray, Inc.1915%
Shimadzu Corporation119%
Drgem Corporation87%
Fujifilm Corporation76%
Ge Medical Systems, L.L.C.65%
Carestream Health, Inc.65%
Siemens Healthcare Gmbh54%
Micro-X Limited54%
Agfa43%
Samsung Electronics Co., Ltd.32%
Solutions For Tomorrow Ab22%

Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

!M1TrueMobileuDRDR 100sDX-D 100FDR AQROTransportation carriageAdded filterMobirex i9MobileDaRt EvolutionFDR GoMobileArt EvolutionAmadeo M-DR miniMOBILETT ImpactMOBILETT Elara MaxMobilett Mira Max

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

FDA product codes

CodeNameDevices
IZLSystem, X-Ray, Mobile117
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)91
IZLSystem, x-ray, mobile31
LLZSystem, Image Processing, Radiological19
MQBSolid state x-ray imager (flat panel/digital imager)5
EHDUnit, X-Ray, Extraoral With Timer2

GMDN & GCC registration

  • GMDN code 37647 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 83% · 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) · 4

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

How many mobile basic diagnostic x-ray system, digital products are registered in the US?

123 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Mobile basic diagnostic x-ray system, digital", from 20 companies. The largest labeler is Sedecal with 30% of records.

Which FDA product codes apply?

IZL (System, X-Ray, Mobile), MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), IZL (System, x-ray, mobile), LLZ (System, Image Processing, 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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