Fujifilm awarded FDA 510(k) for dry laser imagers with FFDM
The FDA has given 510(k) clearance to Fujifilm Medical Systems USA Inc.'s DryPix dry laser imagers for use with full-field digital mammography (FFDM).
The clearance covers the company's DryPix 7000, DryPix 5000 and DryPix FM-DP L models. The centralized dry laser imagers have both regulatory clearance and inherent features necessary for printing FFDM, as well as computed radiography, MRI, CT and ultrasound.
All three imagers have been tested and validated by FFDM pre-market application (PMA) holders GE Medical Systems, Fischer Imaging Corp. and Hologic Inc.
The clearance covers the company's DryPix 7000, DryPix 5000 and DryPix FM-DP L models. The centralized dry laser imagers have both regulatory clearance and inherent features necessary for printing FFDM, as well as computed radiography, MRI, CT and ultrasound.
All three imagers have been tested and validated by FFDM pre-market application (PMA) holders GE Medical Systems, Fischer Imaging Corp. and Hologic Inc.