Planar Systems Inc. this week received U.S. Food & Drug Administration 510k approval to market its flat-panel Dome C5i system for displaying and viewing mammograms.
FDA approval follows clinical evaluations conducted at the Elizabeth Wende Breast Clinic in Rochester, N.Y. Final evaluation results were published by Ovation Research Group and include specific performance data on display of mass features, calcium features and architectural distortion features, says Planar.
The study was performed in conjunction with evaluations of Fischer Imaging Corp.'s SenoScan full-field digital mammography (FFDM) system. Evaluations demonstrated that Planar's Dome C5i is equivalent to 5 mega-pixel CRT displays of full-field digital mammograms over a wide range of mammography cases.