Device Dossier
X-ray image interpretive software
Device Dossier for X-ray image interpretive software (X-ray image interpretive software, Class IIa, sponsor Emergo). ARTG record, intended purpose, GMDN…
- GMDN category: X-ray image interpretive software
Intended purpose
Software intended to provide preliminary data for helping physicians’ diagnosis of X -rays. The software is intended for use in hospitals/health institutions by medically trained professionals including, but not limited to physicians.