(154 days)
The Suni3D 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 structures by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
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I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the Suni3D computed tomography x-ray system, confirming its substantial equivalence to a predicate device. It specifies the intended use and regulatory information but does not detail performance metrics, study designs, or ground truth establishment.
§ 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.