Device Dossier

Radiology DICOM image processing application software

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

Intended purpose

The application is intended to provide processing, quantification, and multidimensional review of the biodistribution of radionuclides in the body using planar and tomographic images. The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion images. The application supports correlative review and measures of physiologic, functional, and anatomic datasets from multidimensional radiographic images. It provides analytical tools to help the user quantify and document changes in these measures.

TGA Public Summary