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Device Explorer · FDA GUDID · GMDN 58473

Diagnostic x-ray digital imaging system workstation application software

An individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a diagnostic x-ray system workstation so that it may function according to its inten

US‑registered devices122in commercial distribution
Companies18labelers on GUDID
Single‑use18%of device records
Sterile18%labelled sterile
Prescription82%Rx‑only share
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Share of device records

Trackx Technology, Llc6654%
Konica Minolta, Inc.97%
Med.E.Com76%
Siemens Healthcare Gmbh65%
Konica Minolta Medical Imaging U.S.A., Inc.65%
Xoran Technologies Llc43%
Carestream Health, Inc.43%
Carestream Dental Llc43%

Top labelers

CompanyDevicesShare
Trackx Technology, Llc6654%
Konica Minolta, Inc.97%
Med.E.Com76%
Siemens Healthcare Gmbh65%
Konica Minolta Medical Imaging U.S.A., Inc.65%
Xoran Technologies Llc43%
Carestream Health, Inc.43%
Carestream Dental Llc43%
Lg Electronics Inc.32%
Beijing Infervision Healthcare Medical Technology Co., Ltd.22%
Oehm Und Rehbein Gmbh22%
Cerner Corporation22%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

InferCare RECISTInferOperate SuiteDigital Radiographic Imaging Acquisition SoftwarAngio Workstation SoftwareCS-7KONICAMINOLTA DI-X1dicomPACS®dicomPACS®DX-RMAMMOVISTA B.smartsyngo.Breast CareMEDWSLumiGuideXoran WorkstationXoranConnectTrackXCerner SkyVue®

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

FDA product codes

CodeNameDevices
OWBInterventional Fluoroscopic X-Ray System86
LLZSystem, Image Processing, Radiological41
LLZSystem, image processing, radiological14
JAASystem, X-Ray, Fluoroscopic, Image-Intensified5
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)4
DQKComputer, Diagnostic, Programmable3

GMDN & GCC registration

  • GMDN code 58473 · non‑implantable
  • Single‑use 18% · sterile 18% · Rx‑only 82% · 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 application software products are registered in the US?

122 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 application software", from 18 companies. The largest labeler is Trackx Technology, Llc with 54% of records.

Which FDA product codes apply?

OWB (Interventional Fluoroscopic X-Ray System), LLZ (System, Image Processing, Radiological), LLZ (System, image processing, radiological), JAA (System, X-Ray, Fluoroscopic, Image-Intensified)

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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