(26 days)
RAYSCAN a-Expert 3D, panoramic x-ray imaging system with cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBCT technique, to generate dentomaxillofacial 3D images.
RAYSCAN a-Expert 3D, panoramic x-ray imaging system with cephalostat, is an extraoral source x-ray system... The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations.
The provided text is an FDA 510(k) clearance letter for the RAYSCAN a-Expert3D device. It outlines the device's classification, regulatory requirements, and indications for use. However, it does not contain any information about the acceptance criteria or the study that proves the device meets those criteria.
The document states that the device is a Computed Tomography X-ray System (21 CFR 892.1750) for dental radiographic examination. The indications for use describe its capabilities for panoramic examinations, implantology, TMJ studies, cephalometry, and the generation of dentomaxillofacial 3D images using CBCT technique.
Without further documentation (e.g., the 510(k) summary or a detailed clinical/performance study report), it is impossible to provide the requested information regarding acceptance criteria and the study proving the device's performance. The provided text is solely the FDA's clearance notice, not the submission itself or its supporting data.
§ 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.