(168 days)
The Kodak RVG 6500 wireless digital intraoral system is intended to replace dental Xray film for any intraoral diagnostic purposes. It uses the wireless technology in order to transmit the acquire image to a computer. It requires additional components such as conventional extraoral X-ray source and visualization software. The Kodak RVG 6500 IPS System, in addition, provides the Intelligent Positioning System (IPS) to enable the dentist prior to acquisition to correctly align the X-ray beam to the RVG sensor.
Not Found
This document is an FDA 510(k) clearance letter for the Kodak RVG 6500 System and Kodak RVG 6500 IPS System. It declares the device substantially equivalent to legally marketed predicate devices.
The letter itself does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the regulatory clearance process, stating that the device is substantially equivalent to existing devices and falls under general controls and potentially special controls for Class II devices.
Therefore, I cannot provide the requested information from the provided text. The document is a regulatory approval, not a performance study report.
§ 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.