(246 days)
The CS 9300 and CS 9300C are systems intended to produce two-dimensional and three-dimensional digital x-ray images of the dento-maxillo-facial, and ENT (Ear, Nose and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
In addition, the CS 9300C is intended to produce cephalometric images. This includes imaging the hand and wrist to obtain the carpus image for growth and maturity assessment.
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This document is a 510(k) clearance letter for the CS 9300 and CS 9300C computed tomography x-ray systems. It outlines the FDA's determination of substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria, reported device performance data, details of a study (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or information on ground truth establishment for a training set.
Therefore, I cannot fulfill your request for that detailed information based solely on the provided text. The document confirms the device's clearance for marketing based on substantial equivalence, but it does not present the technical study details you are asking for.
§ 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.