Search Results

The CS 8100 3D is intended to produce or segmented tonographic digital panoramic images and three-dimensional digital X-ray images of the dento-naxillofacial area to be used at the direction of healtheare professionals as diagnostic support for pediatic and adult patients.

In addition, the CS 8100 3D is provided with a radiological cram option which allows the display of one determined third molar segment of the dental structures using the capability of the system to explore cach slice acquired during an exam.

Not Found

This document is an FDA 510(k) clearance letter for the CS 8100 3D device. It confirms that the device has been found substantially equivalent to legally marketed predicate devices. However, this document does not contain the specific details of acceptance criteria or the study that proves the device meets those criteria.

FDA 510(k) clearance letters typically refer to the manufacturer's submission for those details. Without access to the original 510(k) submission (K133406), it's impossible to answer your questions regarding acceptance criteria, study design, sample sizes, ground truth establishment, or any comparative effectiveness studies.

Therefore, I cannot provide the requested information based solely on the provided text. The document confirms the clearance of the device based on a determination of substantial equivalence, but it does not describe the performance testing in detail.

Ask a specific question about this device