(25 days)
Kodak 2100 and Kodak 2200, intra-oral X-ray generators are intended for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
Not Found
I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for the Kodak 2100 and Kodak 2200 intra-oral X-ray generators. It confirms that the devices are substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.
To answer your request, I would need a document that describes the specific performance metrics, the study design, and the results of a validation study for the device.
§ 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.