(29 days)
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.
§ 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.