(45 days)
Respiratory Gating is an option for CT scanners of the Sensation and the Emotion family. This application provides an improvement of the image quality by removing the artifacts caused by respiratory motion.
The computed tomography system in combination with a device for Respiratory Gating is intended for the removal of the artifacts caused by respiratory motion. This leads to an increase of the image quality and advancement in diagnosis because the movement of organs or tumors can be visualized against the respiration phases.
This document does not contain the information necessary to fulfill your request. It is a 510(k) summary for a Siemens Respiratory Gating device, outlining its substantial equivalence to previously cleared devices.
Specifically, it lacks:
- A table of acceptance criteria and reported device performance.
- Details about any specific study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
The document primarily focuses on regulatory submission details such as contact information, device classification, and indications for use, rather than detailed performance data or study specifics.
§ 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.