Advanced Diagnostics Inc.

The digitized image is then analyzed by proprietary signal processing software which highlights "regions of interest" (ROIs) with the following characteristics:Clusters of bright spots (i.e., regions suggestive of microcalcification clusters,dense regions and dense regions with radiating lines (i.e., regions suggestive of masses or architectural distortions).

The ImageChecker® System marks particular ROIs because of their physical characteristics. The marked ROIs are associated with a visually perceptible structure that has some of the generally accepted geometric characteristics of microcalcifications. or masses. The marked areas may be something other than an actual abnormality, but these are recognized as such by the radiologist upon review of the original mammogram.

Importantly, the ImageChecker® System is not a diagnostic device, as only the original mammograms may be used for interpretation by the radiologist. By design, the device produces only low-resolution images on its monitors to preclude their use for diagnostic interpretation.

Processor Unit
To process the cases, the films are scanned using the 50-micron Film Digitizer. The resultant digitized image is a 12-bit image producing excellent spatial and contrast resolution. A bar-code reader is also supplied on the input device to identify case films. Input to the Processing Unit is provided by a specialized and easy-to-use interface, designed to maximize the efficiency of clinical workflow in the mammography suite. Input to the Processing Unit is provided by a specialized and easy-to-useinterface, designed to maximize the efficiency of clinical workflow in the mammography suite. Once the films are scanned, the digitized images are processed with the proprietary neural network algorithms resulting in approximately a billion operations per film. The time from scan to digitized display is approximately four minutes per case. ImageChecker®- CL

An Ethernet connection is available for local sites (some restriction may apply). This connection transfers the processed R2 image file from the Processing Unit to the Display Unit.

Original mammograms are conventionally displayed on the Display Unit without any obstruction or marking. A Bar Code Reader is provided as part of the Display Unit, to identify case films and allow random access to the queue of low-resolution images.

To interpret a case, the radiologist reviews the mammograms (typically two views each of the left and right breast) mounted on the Display Unit for conventional interpretation. The radiologist then activates the ImageChecker® System display unit to review the low resolution marked images on the two, video display monitors installed on the console below the light boxes. The radiologist may then review the original mammograms again, paying particular attention to any areas of the images designated by the markers and revise their interpretation. R2 has flexible configurations to meet the needs of various clinical settings. The CheckMate™ Ultra is an on-line viewing option that can be integrated with one or more ImageChecker® Processing Units. The flat panel touch screen display system allows immediate review of CAD results after processing. An attached barcode reader correlates patient information accurately, eliminating input errors.