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The ImagClear® System is intended to digitize analog medical images, which will be viewed, archived, or electronically shared with other health care professionals. The ImagClear® System is specifically indicated for the digitization of mammographic images for review and analysis, but not as the sole basis for screening or diagnosis.

Essentially, the ImagClear® System is composed of two previously cleared devices: (1) the ImagClear® Film Digitizer, which DBA obtained FDA 510(k) clearance for use as a medical film digitizer with a mammography indication; and (2) a modified version of the previously Galen™ Software. The interfacing of these two previously cleared devices raise no new questions of safety or effectiveness because it does not alter the intended use of either device. The first component of the ImagClear® System, the ImagClear® Film Digitizer, is a CCD-based digitizer which provides 16 bits of grayscale resolution. It produces at minimum a 4K x 5K image matrix, which is adequate for high quality mammography films. The second component of the ImagClear® System, the modified Galen™ Software, organizes the digitized mammography images into studies and sessions. The digitized mammogram studies and sessions may be viewed by using an overall or bilateral display (i.e., display provides comparisons between left and right breasts or old and new images). The software also allows physicians or technicians to create online mammography reports. In addition, the digitized mammogram studies and sessions and on-line reports may be viewed, archived on a central file server, or electronically shared with other health care professionals.