OEC One ASD
GE Hualun Medical Systems Co. Ltd.The OEC One ASD is a mobile C-arm X-ray system designed to provide fluoroscopic and digital spot images during diagnostic, interventional, and surgical procedures across various clinical specialties. It helps clinicians visualize patient anatomy in real-time to aid procedure guidance and decision making. The device uses advanced flat panel detector technology to enhance image quality and supports ease of use with features such as a touchscreen monitor, integrated printer shelf, and improved software architecture.
Intended Use
The OEC One ASD mobile C-arm system is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures including orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures.
Technology
The device utilizes an amorphous silicon flat panel detector that replaces the image intensifier to improve image quality with higher detective quantum efficiency and modulation transfer function. It includes a mobile stand with articulating arm, a ‘‘C’’-shaped arm with X-ray source and flat panel detector, and is capable of linear and rotational motions for positioning. Software is updated to a platform-based architecture supporting imaging acquisition and post-processing features. Integrated hardware upgrades also include a touchscreen monitor with higher resolution, tablet with updated OS, and wireless printer capability.
Performance
Verification and validation testing were successfully completed including design control procedures, risk analysis, performance and safety testing, and simulated use testing. The system complies with multiple FDA-recognized standards (IEC 60601-1 series, IEC 62304, IEC 62366-1, NEMA XR-27, etc.) and FDA guidances. Comparative clinical images and engineering bench testing demonstrated substantial equivalence to the predicate device with no new safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/26/2024
9 months - 2
FDA Approval
12/27/2024
Other devices from GE Hualun Medical Systems Co. Ltd.
- Definium Pace Select ET2024 • 510K
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