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Acquisition and display of axial x-ray images of the whole body to include the head.

The TSX-301A/1 is a whole body CT scanner. This device produces axial images that may be reconstructed into 3-D volumes. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display.

This 510(k) premarket notification for the TSX-301A, Aquilion ONE CT System from Toshiba America Medical Systems, Inc. does not contain information regarding
acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document focuses on:

• Device description: A whole-body CT scanner that produces axial images reconstructable into 3D volumes.
• Intended Uses: To produce cross-sectional data sets of the anatomy.
• Technological Characteristics: Similar materials and processes to its predicate device, the Toshiba TSX-101A/H Aquilion 64 SP CT scanner.
• Safety and Effectiveness Concerns: Designed and manufactured under Quality System Regulations (21 CFR § 820.30) and Federal Diagnostic Equipment standards (21 CFR § 1020.30 and 1020.33). Conforms to applicable parts of IEC 60601-1, IEC 60601-2-32, and IEC 60601-2-44.
• Substantial Equivalence: Claimed to be substantially equivalent to the Toshiba TSX-101A/H Aquilion 64 SP CT scanner.
• FDA Clearance: The FDA found the device substantially equivalent to a legally marketed predicate device on November 3, 2006.
• Indications for Use: Acquisition and display of axial x-ray images of the whole body, including the head.

Therefore, I cannot provide the requested table and study details as they are not present in the provided text.

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