Consulting Wallah › Device Explorer › Dental › General-purpose dental x-ray system application so
Device Explorer · FDA GUDID · GMDN 40876

General-purpose dental x-ray system application software

"An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose dental x-ray system configuration. A basic set of applications programs and routines are included

US‑registered devices76in commercial distribution
Companies17labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription63%Rx‑only share
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Share of device records

Ewoo Soft Co., Ltd2938%
Imageworks811%
Carestream Dental Llc79%
Midmark Corporation68%
Carestream Health, Inc.57%
Dürr Dental Se34%
Apteryx Inc34%
Dgnct Llc23%

Top labelers

CompanyDevicesShare
Ewoo Soft Co., Ltd2938%
Imageworks811%
Carestream Dental Llc79%
Midmark Corporation68%
Carestream Health, Inc.57%
Dürr Dental Se34%
Apteryx Inc34%
Dgnct Llc23%
Masterlink Llc23%
Suni Medical Imaging, Inc.23%
Cyber Medical Imaging, Inc.23%
Hdx Will Corp.23%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

VisionXVistaSoftImageXLSOTA Cloud ImagingDenti.AI Auto-ChartSegmentron ViewerDiagnocatApex Cloud SoftwareApex Capture SoftwareEVASOFTEVA SELECT DIRECTEVA SELECTDR SuniProf SuniProgeny imaging DomesticMidmark Progeny Imaging Software

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

FDA product codes

CodeNameDevices
LLZSystem, Image Processing, Radiological52
MUHSystem,X-Ray,Extraoral Source,Digital16
LLZSystem, image processing, radiological14
QIHAutomated Radiological Image Processing Software4
MYNAnalyzer,Medical Image3
MYNAnalyzer, Medical Image2

GMDN & GCC registration

  • GMDN code 40876 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 63% · 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 general-purpose dental x-ray system application software products are registered in the US?

76 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General-purpose dental x-ray system application software", from 17 companies. The largest labeler is Ewoo Soft Co., Ltd with 38% of records.

Which FDA product codes apply?

LLZ (System, Image Processing, Radiological), MUH (System,X-Ray,Extraoral Source,Digital), LLZ (System, image processing, radiological), QIH (Automated Radiological Image Processing Software)

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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