(70 days)
The ScanX Scanner is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose.
The ScanX Scanner is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory.
The provided document is an FDA 510(k) clearance letter for the SCANX Scanner. It states that the device is "substantially equivalent" to a legally marketed predicate device. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than requiring new clinical trials to establish safety and effectiveness and detailed performance metrics as would be found in a PMA submission or a detailed study report.
Therefore, I cannot provide the requested information based on the given text. The document confirms the regulatory clearance but lacks the technical and performance data asked for in your prompt.
§ 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.