Intended Purpose of IMORAY

Version 1.11 — effective 28 October 2026

Purpose

IMORAY is intended to assist authorised radiology professionals with faithful transcription, organisation, structuring and drafting of information they provide into editable text. The application also offers productivity, educational and reference tools that are separate from the report.

Users and environment

Clinical reporting features are intended for radiologists and authorised professional staff on devices and networks managed by the user or their organisation. A personal subscription may be bought by a natural person as a consumer, but that contractual status does not expand the clinical purpose or authorise an unqualified person to use output for patient care. The product is not intended for patients, minors or use as a direct medical service by the general public.

Inputs

Depending on the selected feature, input may include:

• the professional's dictation or text;
• a template selected by the user;
• an anonymised previous report for comparison;
• explicit instructions to revise an existing generated text;
• anonymised documents supplied for style adaptation;
• a general question and public sources for Pathology Summary or Xira.

Users must not provide direct patient identifiers. IMORAY does not need patient names, national identification numbers, contact details or case numbers for reporting features.

Output

The principal output is editable text: a transcription, report body, impressions, comparison or revision. Content is displayed for user review and correction. IMORAY does not sign, professionally stamp, transmit into a clinical system or autonomously finalise a report.

AI-assisted impressions summarise user-supplied content and must be verified. Visual highlights show textual correspondence and are not image detection. Pathology Summary and Xira are separate informational tools and do not make patient-specific recommendations.

Included features

• dictation and transcription in the selected clinical language;
• report drafting from user text and the selected template;
• editable impressions;
• successive change requests against the current version;
• comparison with an anonymised previous report;
• OCR for text, without diagnostic image interpretation;
• checks for fidelity, structure and textual consistency;
• personal and educational templates;
• anatomy atlas, Pathology Summary and the Xira assistant.

Excluded uses

IMORAY is not intended to:

• autonomously interpret DICOM images or detect lesions;
• establish a diagnosis, treatment, triage, urgency or patient-specific recommendation;
• replace professional review or issue an unsupervised final report;
• be used by a patient for self-diagnosis;
• be the sole basis for a clinical decision;
• receive direct patient identifiers through the application, support or email.

Human oversight

The professional compares the text with images, source data and available context, corrects any error and decides whether and how to use it in their authorised workflow. Any AI feature may produce omissions, unsuitable wording or unavailability. Medical responsibility remains entirely with the professional and their organisation.

Status and changes

This description defines the public functional boundary of the current version. It is not a certification or medical-device classification. Any extension into image analysis, diagnosis, triage, recommendations or autonomous finalisation requires a separate assessment before activation.