Consulting Wallah › Device Explorer › Equipment & monitoring › X-ray image interpretive software
Device Explorer · FDA GUDID · GMDN 63386

X-ray image interpretive software

An interpretive software program intended to be used to analyse non-dental x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provid

US‑registered devices108in commercial distribution
Companies26labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription84%Rx‑only share
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Share of device records

Brainomix Limited4643%
Azmed98%
Screenpoint Medical B.V.76%
Imbio, Llc66%
Lunit Inc.66%
Ge Medical Systems, L.L.C.44%
Imagen Technologies, Inc.33%
Harrison-Ai Medical Pty Ltd33%

Top labelers

CompanyDevicesShare
Brainomix Limited4643%
Azmed98%
Screenpoint Medical B.V.76%
Imbio, Llc66%
Lunit Inc.66%
Ge Medical Systems, L.L.C.44%
Imagen Technologies, Inc.33%
Harrison-Ai Medical Pty Ltd33%
Beijing Infervision Healthcare Medical Technology Co., Ltd.22%
Medcognetics Inc22%
Therapixel22%
Artrya Usa Inc.22%

Company = labeler of record on GUDID. 26 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

InferRead Lung CT.AIInferRead CT Stroke.AIRBkneeOsteoSightSmartChestRayvolveMammo DxRevealAI-LungCognet AIChestSuiteChest-CADFractureDetect (FX)IQ-UIPImbio PHAImbio RV/LVClairity Breast

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, Radiological27
QIHAutomated Radiological Image Processing Software21
QASRadiological Computer-Assisted Triage And Notification Softw19
QDQRadiological Computer Assisted Detection/Diagnosis Software 14
QBSRadiological Computer Assisted Detection/Diagnosis Software 11
QFMRadiological Computer-Assisted Prioritization Software For L9

GMDN & GCC registration

  • GMDN code 63386 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 84% · 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 x-ray image interpretive software products are registered in the US?

108 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "X-ray image interpretive software", from 26 companies. The largest labeler is Brainomix Limited with 43% of records.

Which FDA product codes apply?

LLZ (System, Image Processing, Radiological), QIH (Automated Radiological Image Processing Software), QAS (Radiological Computer-Assisted Triage And Notification Softw), QDQ (Radiological Computer Assisted Detection/Diagnosis 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.

How do I get quotes?

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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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