(34 days)
The SCT-6800TX is an X-ray CT scanner intended for examinations of the whole body. It is equipped with a slipring , and can perform the spiral CT scanning besides conventional scanning. The SCT-6800TX is basically similar in design , composition and function to the SCT-7000TX ( K955255 ) . Therefore, the intended use of the SCT-6800TX is the same as that of the predicate device SCT-7000TX(K955255).
The SCT-6800TX is an X-ray CT scanner intended for examinations of the whole body. It is equipped with a slipring , and can perform the spiral CT scanning besides conventional scanning. The SCT-6800TX is basically similar in design , composition and function to the SCT-7000TX ( K955255 ) .
The provided documents are a 510(k) clearance letter and a portion of a 510(k) submission for the Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-6800TX. These documents do not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, not necessarily on presenting new clinical performance studies with detailed acceptance criteria of the kind typically seen for AI/ML-driven devices or novel diagnostic tools.
Therefore, I cannot provide the requested information based on the given input.
§ 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.