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The RSV (Radiology System Visiodent) device is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional x-ray films.

This is achieved by using the conventional x-ray tube, but by placing an electronic sensor, instead of film, inside the patient's mouth. The sensor, upon radiation exposure, automatically captures the images into a computer for viewing, storage, printing and manipulation of the x-rays.

The RSV (Radiology System Visiodent) device is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional x-ray films.

This is achieved by using the conventional x-ray tube, but by placing an electronic sensor, instead of film, inside the patient's mouth. The sensor, upon radiation exposure, automatically captures the images into a computer for viewing, storage, printing and manipulation of the x-rays.

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a device named "RSV (Radiology System Visiodent)". It states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications. These details are typically found in the 510(k) submission itself or in a separate summary provided by the manufacturer, neither of which are present in the provided text.

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

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