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The Siemens SOMATOM P30F systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

The Sicmens SOMATOM P30F is a whole body X-ray computed tomography systems, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

The provided text is a 510(k) summary for the Siemens SOMATOM P30F, a Computed Tomography System. It focuses on demonstrating substantial equivalence to a predicate device and outlines the device's description, indications for use, and general safety/effectiveness concerns.

This document does not contain information on acceptance criteria, a study proving device performance against such criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for a performance study.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study that proves the device meets those criteria based on the provided text. The document is primarily a regulatory submission for substantial equivalence.

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