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The digital radiography unit DAR-7000 is a radiography The digital faulography director using the flat panel sensor as X-ray detector. X-ray detector equipped wi':ht sensor as X-ray detector. I ollous user to acquire a high sensor as X-ray detector) allows user to acquire a hiujh-Detector) arrows ason to display divisioing quality image. quality image. Inis system is accuribulate that image dita. This unit is not used for mammography.

The digital radiography unit DAR-7000 is a radiography The digital faulography director using the flat panel sensor as X-ray detector. X-ray detector equipped wi':ht sensor as X-ray detector. I ollous user to acquire a high sensor as X-ray detector) allows user to acquire a hiujh-Detector) arrows ason to display divisioing quality image. quality image. Inis system is accuribulate that image dita. This unit is not used for mammography.

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for the DAR7000 RADspeed SAFIRE device. It does not contain any information about the acceptance criteria, device performance, study design, sample sizes, ground truth establishment, or expert qualifications that you requested.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the given text.

The document primarily focuses on the regulatory status of the device, confirming its substantial equivalence to predicate devices and outlining the applicable regulations. It does not delve into technical performance details or the results of any clinical studies.

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