Instrumentarium gets FDA OK on breast system

December 20, 2000

The FDA gave Instrumentarium Imaging 510(k) clearance to market its Delta 32 3-D breast imaging system and digital stereotactic system. The system provides 3-D and layered viewing for assessment of biopsy depth and wire localization placement.The newly

The FDA gave Instrumentarium Imaging 510(k) clearance to market its Delta 32 3-D breast imaging system and digital stereotactic system. The system provides 3-D and layered viewing for assessment of biopsy depth and wire localization placement.

The newly approved items are part of Instrumentarium's Diamond Breast Care System. The stereotactic feature can image from any two angles, which gives it flexibility and saves procedure time. Although the system is film-based, an amorphous selenium full-field digital upgrade kit is in the works. n