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Device Explorer · FDA GUDID · GMDN 37645

Stationary basic diagnostic x-ray system, digital

An assembly of devices that comprise general-purpose stationary 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. The stationary design requires it to

US‑registered devices662in commercial distribution
Companies46labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription54%Rx‑only share
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Share of device records

Carestream Health, Inc.16825%
Drgem Corporation8913%
Fujifilm Corporation7912%
Shimadzu Corporation629%
Ge Hualun Medical Systems Co., Ltd406%
Radmedix, Llc203%
Imaging Dynamics Company Ltd162%
Konica Minolta Medical Imaging U.S.A., Inc.162%

Top labelers

CompanyDevicesShare
Carestream Health, Inc.16825%
Drgem Corporation8913%
Fujifilm Corporation7912%
Shimadzu Corporation629%
Ge Hualun Medical Systems Co., Ltd406%
Radmedix, Llc203%
Imaging Dynamics Company Ltd162%
Konica Minolta Medical Imaging U.S.A., Inc.162%
Agfa152%
Drtech Corporation152%
Del Medical, Inc.142%
Lodox Systems (Pty) Ltd122%

Company = labeler of record on GUDID. 46 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OMNERA 500AOMNERA 400TOMNERA 400AArtPix Fixed LiteArtPix Mobile LitePresto DR 3543 EZ OptimumPresto DR 4343OptimumPresto DR 4143OptimumArtPiX Mobile EZ2GOuDRX-ray Flat Panel DetectorLODOXLodoxZ-MOTIONDR 400Valory

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

FDA product codes

CodeNameDevices
KPRSystem, X-Ray, Stationary305
KPRSystem, x-ray, stationary229
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)127
MQBSolid state x-ray imager (flat panel/digital imager)120
JAKSystem, X-Ray, Tomography, Computed12
LLZSystem, Image Processing, Radiological10

GMDN & GCC registration

  • GMDN code 37645 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 54% · 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) · 18Height (Centimeter) · 8Length (Millimeter) · 4Width (Millimeter) · 4Height (Millimeter) · 4Area/Surface Area (Square centimeter) · 2

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

662 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Stationary basic diagnostic x-ray system, digital", from 46 companies. The largest labeler is Carestream Health, Inc. with 25% of records.

Which FDA product codes apply?

KPR (System, X-Ray, Stationary), KPR (System, x-ray, stationary), MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), MQB (Solid state x-ray imager (flat panel/digital imager))

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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