Planar gets 510(k) for flat-panel mammo display

Jun 22, 2004

Monitor manufacturer Planar Systems has received 510(k) clearance from the Food and Drug Administration for a 5-megapixel flat-panel display designed for use with full-field digital mammography (FFDM) systems.

Planar claims that the clearance, for its Dome C5i system, is the first time a flat-panel monitor has been cleared for display and viewing of mammograms as part of a full-field digital mammography system, according to the Beaverton, OR, firm.

Planar conducted a clinical study at the Elizabeth Wende Breast Clinic in Rochester, NY, to collect data in support of the 510(k) application, according to Matt Harris, vice president of marketing and corporate development. The study, which will be published in an upcoming issue of the American Journal of Roentgenology, found that the flat-panel monitor was equivalent to, and in some respects outperformed, CRT-based systems, he said.

The clinical study was based on the use of Dome C5i in conjunction with a SenoScan FFDM unit manufactured by Fischer Imaging of Denver. Dome C5i will be sold by Fischer and other FFDM vendors as part of an integrated package, and Planar will also sell the monitor directly to healthcare providers through its existing sales channels, Harris said.

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