Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))
Shenzhen SONTU Medical Imaging Equipment Co., Ltd.The Digital Radiography X-ray System by Shenzhen SONTU Medical Imaging Equipment Co. is a modular digital X-ray system used in hospitals and clinics. It produces high-quality digital images of the whole body, including skull, chest, abdomen, and extremities, helping clinicians diagnose a wide range of conditions. The system supports various patient positions and utilizes digital detectors to convert X-rays into image signals quickly and accurately, enhancing clinical workflow and patient care.
Intended Use
The Digital radiography X-ray system is used in hospitals, clinics, and medical practices. It enables radiographic exposures of the whole body including skull, chest, abdomen, and extremities and may be used on adult and bariatric patients. It is not intended for mammographic applications.
Technology
The device is a modular radiography X-ray system composed of components like ceiling suspensions with X-ray tubes, Bucky wall stands and tables, X-ray generators, portable wireless and fixed integrated digital detectors. It uses digital detectors to generate diagnostic images by converting X-rays into image signals. The system software is basic level of concern and the system is configurable for different customer needs.
Performance
Non-clinical tests including compliance with IEC standards and performance testing of flat panel detectors were conducted. Clinical image evaluations on various body sites showed equivalent diagnostic capability to predicate devices. Software verification and validation were performed demonstrating conformance with safety and effectiveness requirements.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/22/2024
4 months - 2
FDA Approval
1/6/2025
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