Planar receives FDA's first approval for Flat-Panel Display use in mammography; Dome Cx Product Line leads display innovation for diagnostic imaging

Planar Systems, Inc., a worldwide leader in flat-panel display systems, has received FDA 510(k) approval to market the flat-panel Dome(R)C5i system for displaying and viewing mammograms.

Until now, the only FDA approved equipment for all soft copy mammography reviews employed cathode-ray tube (CRT) displays, limiting choice and excluding radiologists from flat-panel technology's image quality, ergonomic and quality-assurance benefits.

FDA approval follows clinical evaluations conducted at the prestigious 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. The study was performed in conjunction with evaluations of Fischer Imaging's SenoScan(R) Full-Field Digital Mammography System. Evaluations demonstrated that Planar's Dome C5i is equivalent to and, in many respects, better than 5MP CRT displays of full-field digital mammograms over a wide range of mammography cases.

"We are pleased to have partnered with Planar and Elizabeth Wende Breast Clinic in the clinical trials of the C5i flat panel displays," said Janine Broda, vice president of marketing of Fischer Imaging, the system partner in the approval process. "Fischer is committed to providing the best possible technology solutions in digital mammography, which includes a broad range of options for managing our customers' digital mammography image solutions. This announcement represents an advancement in imaging displays that further supports our efforts for the early diagnosis of breast cancer."

"With FDA approval of the Dome C5i for use in mammography -- perhaps the most demanding clinical application for display technology -- Planar continues to affirm its market leadership and drive the industry toward adoption of flat-panel display technology," said Steve Flieder, vice president and general manager of Planar's medical business. "We are delighted with the overwhelmingly positive response we received during clinical trials for the Dome C5i and see this as a win for radiologists and their patients, as well as picture archiving and communications systems (PACS) administrators, IT departments and CIOs within the healthcare enterprise."

In addition to the diagnostic benefits of flat-panel displays over CRTs that were supported by Planar's clinical trials, flat panels are a more attractive alternative for quality assurance. CRT monitors degrade over time and require constant inspection and adjustments to maintain optimal performance. Planar's entire Dome Cx line of flat-panel monitors automatically calibrates with Dome CXtra(TM) software to stay in conformance with Digital Imaging and Communications in Medicine (DICOM) standards. The unique software warns users of any deviation from DICOM parameters and produces detailed log information for auditing purposes. Additionally, all of Dome CXtra's quality-assurance functionality can be viewed and managed remotely by IT and quality-assurance departments, reducing the total cost of ownership of the displays.

With another industry first captured by the Dome displays for diagnostic imaging, Planar is enabling a wider range of healthcare facilities to deploy the finest medical displays for improved patient care without compromising on the quality necessary to meet stringent FDA requirements.

Planar's Dome C5i

The Dome C5i exceeds industry standards for diagnostic-quality resolution recommended by the American College of Radiology and the National Electrical Manufacturers Association (ACR-NEMA). It provides 3,061 distinct, displayable gray shades -- nearly three times that of alternative 5MP flat-panel monitors. This provides for precise calibration to DICOM standards, and allows radiologists to distinguish slight variations in a patient's radiograph. Because of its brightness, the Dome C5i can work equally well in bright areas as it does in dark radiology reading rooms.

The line of Dome radiological displays is part of Planar's overall suite of flat-panel based products that serve as the medical world's gateway to patient information. The company's products, developed specifically to meet the rigors of the medical market, also include the VitalScreen(R) line of displays used for patient monitoring and surgical applications, and the Invitium(R) family of point-of-care systems. Planar also provides large plasma screens for patient tracking applications, and desktop monitors used throughout hospital administrative locations.