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The CDCR5020s,UCCR7001 and TCCR7001 are intended to be used in radiological practices as laser digitizers for phosphor storage plate. The images are sent for processing to a PC.

1. Model CDCR 5020s This device is used on cassette based x-ray systems using the standard Buckey exist on every system. After exposing the cassette which includes the phosphor plate ,the plate is digitized and the digital image is transferred to the PC for processing
2. Models UCCR 7001 ,TCCR 7001

With these two devices the organ or object for x-ray exposure are positioned In the front of the device (near the phosphor plate which is positioned into the device) and after exposure the digitizing process is taking place,then the Digital image is transferred to the PC for processing.

The only difference in the models are the way of use eather Vertical for Upright or horizontal under the Radiographic Table.

ALL ABOVE MODELS ARE NOT TO BE USED FOR MAMMOGRAPHY

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The provided text is a 510(k) summary and associated FDA correspondence for "CDCR 5020s, UCCR 7001, and TCCR 7001 CR Readers - COMPUTED RADIOGRAPHY IMAGING SYSTEMS" manufactured by CR TECH LTD.

It outlines that the devices are substantially equivalent to predicate devices, and describes their intended use in radiological practices as laser digitizers for phosphor storage plates. The document, however, focuses on regulatory submission and does NOT contain information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth details.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study proving the device meets those criteria, as this information is not present in the provided text.

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