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Device Explorer · FDA GUDID · GMDN 40866

Basic x-ray clinical assessment support software

A software program intended to display, analyse/process, and possibly acquire static two-dimensional (2-D) x-ray images of bones and/or the abdominothoracic region, acquired by a basic diagnostic x-ray system, to support a healthcare provider with clinical ass

US‑registered devices121in commercial distribution
Companies18labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription75%Rx‑only share
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Share of device records

Icad, Inc.4235%
J.Morita Mfg.Corp.2420%
Siemens Healthcare Gmbh1613%
Eos Imaging87%
Rayence Co., Ltd.76%
Televere Systems, Llc54%
Jpi Healthcare. Co., Ltd.54%
Azmed32%

Top labelers

CompanyDevicesShare
Icad, Inc.4235%
J.Morita Mfg.Corp.2420%
Siemens Healthcare Gmbh1613%
Eos Imaging87%
Rayence Co., Ltd.76%
Televere Systems, Llc54%
Jpi Healthcare. Co., Ltd.54%
Azmed32%
Medimaps Group Sa22%
Konica Minolta, Inc.11%
Fujifilm Corporation11%
Metamorphosis Gmbh11%

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

Brand names on the register (sample)

Bone Suppression Softwarei-DixelSynapse Lung Nodule AIVELYS TraumamyAblation Guidesyngo Application Softwaresyngo.Interventionalsyngo Application Software KITsyngo Application Software MediaRayvolveAutoDensityVEA AlignsterEOSsterEOS®Bunkerhill BMDcmAngio

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
MYNAnalyzer,Medical Image26
LLZSystem, image processing, radiological13
MYNAnalyzer, Medical Image9
QIHAutomated Radiological Image Processing Software8
QBSRadiological Computer Assisted Detection/Diagnosis Software 3

GMDN & GCC registration

  • GMDN code 40866 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 75% · 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 basic x-ray clinical assessment support software products are registered in the US?

121 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Basic x-ray clinical assessment support software", from 18 companies. The largest labeler is Icad, Inc. with 35% of records.

Which FDA product codes apply?

LLZ (System, Image Processing, Radiological), MYN (Analyzer,Medical Image), LLZ (System, image processing, radiological), MYN (Analyzer, Medical Image)

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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