(28 days)
The Xplorer 1100 motorized patient table with digital radiographic detector (510k submission device) is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to lake a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient lying in the brone por supplie posilions.
The Xplorer 1100 (510k submission device) is not intended for mammography.
Xplorer 1100 motorized patient table with digital radiographic detector
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details. This document is a 510(k) clearance letter from the FDA for a device called "Xplorer 1100 Motorized patient table with digital radiographic detector," and it primarily discusses regulatory classification and marketing authorization. It does not contain results from performance studies.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.