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This device is intended to be used in radiology. This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view. This limits the potential for radiation to the general population in the exam area. This device is for diagnostic use.

This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view.

The provided text is a 510(k) premarket notification letter from the FDA to Shimadzu Corporation regarding their R-300 device, a diagnostic x-ray beam-limiting device (collimator).

This document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, it's a letter stating that the FDA has reviewed the 510(k) submission and determined the device is substantially equivalent to legally marketed predicate devices. This means the FDA believes the new device is as safe and effective as a device already on the market without requiring new clinical trials or extensive performance studies.

Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies, as this document does not contain that level of detail. The information presented is focused on regulatory approval based on substantial equivalence to existing devices, not on de novo performance testing against specific acceptance criteria.

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