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Device Explorer · FDA GUDID · GMDN 37644

Stationary basic diagnostic x-ray system, analogue

An assembly of devices that comprise a general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It is typically an x-ray film based system that use analogue or analogue-to-digital techniques for image c

US‑registered devices340in commercial distribution
Companies9labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription59%Rx‑only share
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Share of device records

Drgem Corporation17852%
Carestream Health, Inc.13540%
Arquilla, Inc.144%
Sedecal72%
Osko, Inc.21%
Siemens Shanghai Medical Equipment Ltd.10%
Ge Hualun Medical Systems Co., Ltd10%
Uih Technologies Llc10%

Top labelers

CompanyDevicesShare
Drgem Corporation17852%
Carestream Health, Inc.13540%
Arquilla, Inc.144%
Sedecal72%
Osko, Inc.21%
Siemens Shanghai Medical Equipment Ltd.10%
Ge Hualun Medical Systems Co., Ltd10%
Uih Technologies Llc10%
Gemss Healthcare Co., Ltd.10%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Multix Fusion VA10DCXXR5ProteusuDRX-CEL X-RAY CORPORATIONDRX - Ascend SystemQ-RAD SystemXVISION-525GXR-ES,ECS Diagnostic X-ray SystemFDR ClinicaDRGEMSEDECAL

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, Stationary204
KPRSystem, x-ray, stationary148
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)5

GMDN & GCC registration

  • GMDN code 37644 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 59% · 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 stationary basic diagnostic x-ray system, analogue products are registered in the US?

340 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, analogue", from 9 companies. The largest labeler is Drgem Corporation with 52% 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))

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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