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To provide dosimetry or to detect the dose delivered to a patient during therapeutic radiation procedures. The system is intended for the verification of the output of radiation producing devices.

MOSFET AutoSense Wireless

I am sorry, but the provided text only contains an FDA clearance letter for a medical device (MOSFET AutoSense Wireless) and its indications for use. It does not contain any information regarding acceptance criteria, study details, device performance data, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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To provide dosimetry or to detect the dose delivered to a patient during therapeutic radiation procedures. The system is intended for the verification of the output of radiation producing devices.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a device called "TN-RD-60 Patient Dose Verification System" (later referred to as "MOSFET AutoSense Patient Dose Verification System"). This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

The document does not contain specific acceptance criteria or details of a study proving the device meets those criteria. Such information would typically be found in the 510(k) submission itself, which is not provided here. The clearance letter only confirms that the FDA has reviewed the submission and made a substantial equivalence determination based on the provided information.

Therefore, I cannot provide the requested information from the text.

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Ask a specific question about this device