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The GM85 Digital Mobile X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

The GM85 Digital Mobile X-ray Imaging System is used to capture images by transmitting X-ray to a patient's body. The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process on the S-Station, which is the Operation Software (OS) of Samsung Digital Diagnostic X-ray System, and save in DICOM file, a standard for medical imaging. The captured images are tuned up by an Image Post-processing Engine (IPE) which is exclusively installed in S-Station, and send to the Picture Archiving & Communication System (PACS) sever for reading images. The GM85 Digital Mobile X-ray imaging System was previously cleared with K181626, and through this premarket notification, we would like to add more configurations in the previously cleared GM85 as an optional collapsible column type with a manual collimator, a tube, four detectors, and exposure switches (two wired and one wireless types) are optionally added, and software including the Image Post-processing Engine (IPE) is changed in order to support new hardware and apply new software features.