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Intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).This device is not intended for mammography.

This SR-1000/SR-1000S Portable DR Imaging System is a portable digital device developed, designed and manufactured by SIUI. The device consists of the following major components: a portable X-ray unit, a flat panel detector, and workstation. The difference between SR-1000 and SR-1000S is the operation interface of the portable X-ray Unit only, while the flat panel detector and the workstation are the same for SR-1000 and SR-1000S. The SR-1000S has the display interface with button-operation digital tube, while the SR-1000 has the display interface with touch screen operation. Except for the difference above, the 2 models (SR-1000 and SR-1000S) are completely the same in all the other mechanical and circuit design.

I am sorry, but based on the provided text, there is no information about acceptance criteria, reported device performance, sample size, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details.

The document is a 510(k) summary for a portable DR imaging system, focusing on demonstrating substantial equivalence to a predicate device based on non-clinical testing and comparison of technical characteristics. It explicitly states that "Clinical testing is not necessary for the SR-1000/SR-1000S Portable DR Imaging System in order to demonstrate substantial equivalence to the predicate device." Therefore, there would not be a study proving device performance against specific acceptance criteria in the way you've outlined for a clinical performance study.

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