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Device Explorer · FDA GUDID · GMDN 61109

Diagnostic x-ray digital imaging conversion system

An assembly of medical devices designed to convert an existing analogue x-ray system to digital (i.e., retrofit) through the acquisition and processing of digital images using existing analogue x-ray system components. As a system it consists of both: 1) a fil

US‑registered devices78in commercial distribution
Companies8labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription87%Rx‑only share
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Share of device records

Fujifilm Corporation4862%
Konica Minolta Medical Imaging U.S.A., Inc.1114%
Drtech Corporation68%
Imaging Dynamics Company Ltd45%
Samsung Electronics Co., Ltd.45%
Rf Co.,Ltd.23%
Philips Medical Systems Dmc Gmbh23%
Carestream Health, Inc.11%

Top labelers

CompanyDevicesShare
Fujifilm Corporation4862%
Konica Minolta Medical Imaging U.S.A., Inc.1114%
Drtech Corporation68%
Imaging Dynamics Company Ltd45%
Samsung Electronics Co., Ltd.45%
Rf Co.,Ltd.23%
Philips Medical Systems Dmc Gmbh23%
Carestream Health, Inc.11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAOMIFDR ES II C25FDR ES II C43FDR ES II C35FDR ES II G43FDR ES II G35FUJIFILM APLi-polymer BATTERY CHARGERLi-Polymer Battery PackDR-ID 1280PBDR-ID 1280MPDR-ID 1285SEDR-ID 1284SEDR-ID 1283SEDR-ID 1282SEDR-ID 1281SE

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

FDA product codes

CodeNameDevices
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)42
MQBSolid state x-ray imager (flat panel/digital imager)35
KPRSystem, X-Ray, Stationary3

GMDN & GCC registration

  • GMDN code 61109 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 87% · 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) · 4Height (Millimeter) · 4Width (Millimeter) · 4Length (Millimeter) · 4

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

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

78 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 conversion system", from 8 companies. The largest labeler is Fujifilm Corporation with 62% of records.

Which FDA product codes apply?

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

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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