Lexmark has announced that it received 510(k) Class II clearance from the FDA for the NilRead enterprise viewer. Providers in the U.S. are now able to use the web-based, zero-footprint viewer to review and interpret a variety of imaging studies, including mammography and digital breast tomosynthesis.
The 510(k) Class II clearance is the first for a zero-footprint viewer that supports mammography and tomosynthesis, according to Claudio Gatti, chief technology officer, visualization, for Lexmark Enterprise Software.
NilRead comes in multiple configurations for different workflows, including core, clinical and interpretation. The FDA clearance includes the entire NilRead product family
Lexmark picked up the NilRead line of medical image viewing products in January when it acquired Toronto-based Claron Technology.