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The R-30H is used to take the radiography of patients. The intended for use of the R-30H are also the same as of the predicate beam limiting device R-30H (K031771).

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the R-30H. The document is an FDA 510(k) clearance letter for the R-30H, an angiographic x-ray system. It states that the device is substantially equivalent to a predicate device and can be marketed, but it does not detail any performance studies, acceptance criteria, or specific metrics.

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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.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Beam Limiting Device R-30H). This document does not contain information about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment for a device's performance.

The letter's purpose is to state that the FDA has reviewed the manufacturer's premarket notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It focuses on regulatory compliance rather than detailed performance study results.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text.

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