(61 days)
The syngo Expert-I option for all Siemens CT systems is intended to allow a remote access to the syngo CT workplace from clients inside the local area network.
The syngo Expert-I option allows the local user of the syngo CT workplace to get help and assistance from other personnel on the local area network (LAN) to perform an evaluation of images faster and more efficiently. For this purpose, a remote user within the LAN can log on to the syngo CT workplace.
The provided document is a 510(k) summary for syngo Expert-I. It primarily describes a remote access software for CT systems and confirms its substantial equivalence to a previously cleared device. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.
Therefore, I cannot provide the requested information. The document focuses on administrative and regulatory aspects rather than detailed technical validation of a device's performance.
§ 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.