Search Results

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.

Ask a specific question about this device