(141 days)
The Kub250 is intended for us by a qualified/trained physician or technician for generating, and displaying diagnostic radiographic images of neonatal patients. The Kub250 is not intended for mammography applications.
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This document is a 510(k) premarket notification decision letter for the Kubtec X250 (Kub250) mobile x-ray system, stating that the device is substantially equivalent to a predicate device. It indicates the intended use of the device for generating and displaying diagnostic radiographic images of neonatal patients, excluding mammography applications. It does not contain information about acceptance criteria, device performance studies, or details about AI algorithms.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment based on this document.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.