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The PS 3000 Digital PhotoSpot System " is a high resolution, digital imaging system designed for Digital Videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy and angiography or cardiac imaging procedures are performed. The PS 3000 Digital PhotoSpot System " is indicated for use when it is necessary for a trained health care professional (for example an Radiologist) to acquire, record, review and distribute a digital image from a x-ray image intensifiers in diagnostic imaging chains. The PS 3000 Digital PhotoSpot System " is a prescription device. The labeling, instructions and user operations are designed for trained professionals.

This device can be described as a Class II diagnostic system that receives an image from an image intensifier tube and acquire, record, display and publish diagnostic images using proprietary techniques. This device is composed of: - software {that runs in a qualified, ancillary computer}, . - proprietary hardware and software, and a ● - CCD Camera that receives the image. . All ancillary equipment, which works with this device, is identified as a configured item and tested to formal procedures. This device will only be used with specific ancillary equipment, which is tested and qualified to work with PS 3000 Digital PhotoSpot System ***. The scientific concept on which this device is based that by monitoring images from the image intensified tube a valid diagnostic image can be derived and reproduced. This device functions by converting an optical (analog) image to a digital image having sufficient diagnostic properties as to assist the physician in establishing a diagnosis. The intended use of this device is for a trained health care professional to produce a diagnostic inage. The PS 3000 Digital PhotoSpot System " uses sophisticated digital signal processing and data collection/display techniques to offer the physician or trained health care provider, a reliable, simple tool.