(81 days)
The CS 8100 Access and CS 8100 are intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy as diagnostic support for pediatric and adult patient.
In addition, the CS 8100 is provided with a radiological exam option which allows the display of one determined segment of the dental structures using the capability of the system to explore each slice acquired during an exam.
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This document is a 510(k) clearance letter for a dental X-ray system, not a study report. It states that the device is substantially equivalent to a predicate and confirms regulatory compliance. Therefore, the requested information about acceptance criteria, study details, and performance metrics is not available within this document.
The document discusses the regulatory approval process and general controls but does not contain a scientific study of the device's performance or its acceptance criteria from such a study.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.