(35 days)
The ProMax, Panoramic X-ray Imaging System with Cephalostat, is an extraoral source X-ray System, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, Jaw, and oral structures. The configuration of the system with accessories to fulfil the different diagnostic needs. In usual communication the images are displayed on a monitor, and different diagnostic functions are performed via a computer.
Not Found
I am sorry, but the provided text does not contain the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called "Promax, Panoramic X-Ray Unit with Cephalostat". It indicates that the device has been found substantially equivalent to legally marketed predicate devices and can now be marketed.
However, the document does not include:
- A table of acceptance criteria and reported device performance.
- Details on sample sizes, data provenance, or ground truth establishment for a study.
- Information about expert involvement or adjudication methods.
- Any mention of a multi-reader, multi-case study or standalone algorithm performance.
Therefore, I cannot provide the requested information based on the given 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.