(319 days)
The PaX-Uni3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
The PaX-Uni3D diagnostic equipment consists of Digital Computed Tomography, Panoramic, and Cephalometric dental X-ray system. This device is a system based on Digital X-ray Imaging System (Computed Tomography Sensor to Capture X-ray Digital Computed Tomogram Scanned Image)
The provided document is a 510(k) summary for a dental X-ray imaging system (PaX-Uni3D). It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria related to AI or algorithm performance.
The safety and effectiveness data mentioned in section 8 refers to compliance with electrical, mechanical, environmental, and EMC standards (IEC 60601 series). This is standard for medical devices but does not involve AI performance evaluation.
Therefore, I cannot provide the requested table and study details as the information is not present in the provided text. The document focuses on showing substantial equivalence to a predicate device based on general safety and performance standards for an imaging system, not on the performance of a diagnostic algorithm or AI.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.