Device Dossier
X-ray image interpretive software
Device Dossier for X-ray image interpretive software (X-ray image interpretive software, Class IIb, sponsor Compliance Management Solutions). ARTG…
- GMDN category: X-ray image interpretive software
Intended purpose
This software is used to store, transfer and display output results by inquiring and analyzing medical images with segmentation and quantification functions. It provides to the physician quantitatively in the diagnostic aid, evaluation, and documentation by providing image segmentation of sub-structures. This software must be used by a medical expert (e.g., physician, radiologist) who is very aware of the anatomic structures of a patient.