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

The device is intended for pre-procedural planning of structural heart and vascular procedures using medical images. The software enables clinicians to visualize, measure, annotate and edit data, and to evaluate procedural planning of structural heart and vascular devices. It is intended to be used in conjunction with other diagnostic tools and expert clinical judgement.

TGA Public Summary