Search Results

The Galaxy R Digital Radiography Upgrade is indicated for use in generating radiographic images of human anatomy. It is intended to replace a radiographic film/screen system in all general purpose diagnostic procedures. Not for mammography.

This device is medical image acquisition device. X-rays generated by X-ray generator/ tube that penetrate patient's body are converted to a digital file by the detector. After that the detector sends this digital file to a personal computer (via Ethernet) where the companion software has been installed. This software was cleared in our previous submission, K132921, and it has not been modified. A monitor displays this image. Images can then be transferred via the DICOM protocol. There are four models available, two are 14″ x 17″ and two are 17″ x 17″ (Available in either CSI or GOS scintillator versions). The user must supply the x-ray generator and tubestand to form a full system. Exposure can be Generator Synchronous, or via - AED (Auto Exposure Detection). The technology is Amorphous Silicon (a-Si) Photodiode coupled with either the Gadox or Cesium Iodide scintillators, same as in the predicate.