The GM85 Digital Mobile X-ray Imaging System by Samsung Electronics is a mobile X-ray device designed to generate digital radiographic images of human anatomy. It uses advanced digital detectors and software for image processing and communication with hospital information systems, aiding clinicians in efficient and accurate imaging workflows.
Intended Use
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.
Technology
The GM85 uses an amorphous silicon flat panel detector that absorbs incident X-rays and converts them into digital signals, which are processed and saved as DICOM files. It includes an Image Post-processing Engine (IPE) within the S-Station software for image enhancement and sends images to PACS for review. The system supports wired and wireless communication and includes new configurations like a detector with higher dust and water resistance and lighter weight, plus optional accessories like wireless exposure switches and RFID reader.
Performance
The device underwent electrical, mechanical, environmental safety and performance testing according to various international standards including IEC and ANSI, as well as FDA guidance for solid-state X-ray imaging devices. Non-clinical phantom image evaluations showed equivalent image quality to predicate devices with no adverse impact on safety or effectiveness. No clinical data was required for this submission.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/4/2024
27 days - 2
FDA Approval
10/1/2024
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