Device Dossier

X-ray system, diagnostic, mammographic, stationary, digital

Device Dossier for X-ray system, diagnostic, mammographic, stationary, digital (X-ray system, diagnostic, mammographic, stationary, digital, Class IIb,…

Intended purpose

The Giotto Class and its accessories are designed and built for mammography examination for the screening in modality of full-field Digital mammography (FFDM) and for diagnosis in modality of Digital Breast Tomosynthesis (DBT) for breast cancer detection and cannot be used for other examinations or for the purposes other than those specified by the Manufacturer. Its practical use is therefore exclusively limited to personnel with medical training.

TGA Public Summary