TOTOKU announces FDA 510(k) clearance for ME551i2,
a 5MP monochrome digital mammography display

Tokyo, Japan ― Aug 1, 2006 ―TOTOKU ELECTRIC CO., LTD. received 510(k) clearance for its 5 megapixel monochrome digital mammography LCD display ME551i2 from the U.S. Food and Drug Administration (FDA).

510(k) Number: K061447 Device Name : 5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551i2). Intended Use : 5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551i2) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM. Date of acquisition: July 21, 2006

5M Monochrome Digital Mammography LCD, ME551i2
ME551i2 is a 21.3-inch 5 megapixcel DICOM-calibrated diagnostic display with an 11.9-bit grayscale palette and 750cd/m² brightness. Furthermore, it has a luminance equalizer to achieve highly accurate luminance uniformity across the screen and the capability to simultaneously display 2048 shades of gray (11-bit) to realize smoother and precise grayscale display. Both are musts for digital mammography.

Another notable characteristic of ME551i2 is its display accuracy control capability. The built-in luminance sensor is mounted in front of the screen and monitors luminance constantly to accurately stabilize luminance. An optional performance monitoring software further enables the easy evaluation of DICOM GSDF conformance based on the data measured by the front sensor.

For more information on TOTOKU and its products, visit our website at www.totoku.com or call us at the numbers below.

TOTOKU, founded in 1940 and headquartered in Tokyo, Japan, is a leading manufacturer of high-end medical image displays and touch panels. Since its launch on the display business in 1968, TOTOKU has supplied displays for various fields and has earned high marks for its product reliability under harsh conditions and post installation support, not to mention specialized technologies that are required for the respective fields. TOTOKU’s products and services are available via the US, EU, and Asia offices and distributors throughout the world.

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