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510(k) Data Aggregation
(18 days)
SOMATOM SPIRIT
The SOMATOM Spirit is 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 Siemens SOMATOM Spirit is a whole body X-ray computed tomography stanners, The Siemens SOMATOM 'Spint is a 'Wiole' 600' whole '600' '1. tem' which features a continuously rotaing tube-detector system and functions according to the fan which features a coliminously folling tabe accords of program used for patient beam principle. The system soltware is a control, image reconstruction, and image archive/evaluation.
The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for the SOMATOM Spirit, a Computed Tomography X-ray System, outlining its safety and effectiveness for substantial equivalence to predicate devices. It focuses on the device description, indications for use, technological characteristics, and general safety and effectiveness concerns related to regulatory standards, rather than performance metrics or a detailed study of its capabilities.
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