Device Dossier

Radiology DICOM image processing application software

Device Dossier for Radiology DICOM image processing application software (Radiology DICOM image processing application software, Class IIb, sponsor…

Intended purpose

mint Lesion is a software application intended for structured radiological diagnostics. Specific reading templates enable the systematic analysis and documentation of findings relating to an indication for imaging. The software offers functionality for viewing, analysis, measurement, 3D-visualization, and the comparison of radiological images of different imaging modalities (e.g. CT, MRI, PET.). mint Lesion supports radiologists in the diagnosis of radiological images in clinical settings as well as in clinical patient trials. Depending on the specific task and on the software environment, image data can be imported from PACS systems, and structured information for radiological reports can be generated in different formats and exported to various systems (PACS, RIS/HIS, trial management systems). mint Lesion allows the activation of reading templates that guide the user through the diagnostic process. The template presents mandatory and optional questions, provides or highlights information such as images and prior findings that are relevant in the context of the current work step. Depending on the reading template, further information is automatically deducted from the user’s input. Reading templates are pre-configured for different indications and application areas. This includes for example tumour response evaluation criteria such as RECIST or Lugano, TNM staging of tumours (e.g. for colon carcinoma), and the primary diagnosis of injuries of the musculoskeletal system. mint Lesion is to be used on a dedicated diagnostic imaging workstation. Primary users are radiologists; physicians from other disciplines as well as radiological technologists may also manage the reading process, access information or contribute to the non-radiological aspects of a read. The software can be used within a clinical centre, hospital, radiological practices, research institutes, or in commercial organizations.

TGA Public Summary