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…
- GMDN category: Radiology DICOM image processing application software
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.