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,…
- GMDN category: X-ray system, diagnostic, mammographic, stationary, digital
- Sponsor: GE Healthcare
Intended purpose
This digitial mammography x-ray system is intended to compress and image the breas and to record the absorption pattern of x-ray beams passed through the breast onto various image archive media, e.g. film, paper and digital/video formats. It uses digital techniques for image capture, display and manipulation.It is intended to be used for breast cancer screening and for the placement of biopsy markers, stereotactic biopsy and lesion localization.