(29 days)
Kodak 9000C digital dental panoramic and cephalometric X-ray system is to be used as an extraoral source of X-rays for imaging of the dento-maxillo-facial area.
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The provided text is a 510(k) clearance letter from the FDA for the "Kodak 9000C" digital dental panoramic and cephalometric X-ray system. This document grants market clearance based on substantial equivalence to a predicate device, rather than providing detailed acceptance criteria or a specific study demonstrating performance against such criteria.
Therefore, the information requested in your prompt regarding acceptance criteria, specific study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within this document.
The letter establishes that the device "is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This means the FDA has determined that the new device is as safe and effective as a legally marketed device and does not require a PMA (Premarket Approval) application, which would involve more extensive clinical trials and performance data.
In summary, no information about acceptance criteria or a study proving the device meets them can be extracted from the provided text.
§ 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.