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This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremittestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration.

X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy

The Multislice kit is an upgrade to previously cleared Aquilion CT Scanner, TSX-101A; [K982265]. This upgrade will allow for the collection of multiple axial slices in one scan. This is accomplished by employing multiple solid state detectors. This methodology allows for the acquisition of high resolution slices will maintaining the speed required to reduce anatomical motion artifacts.

I'm sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance metrics. The document is a 510(k) premarket notification summary for an upgrade kit to a CT scanner, focusing on technological characteristics, safety and effectiveness concerns, and substantial equivalence to predicate devices. It does not contain details regarding a clinical study or performance data with acceptance criteria.

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