Diagnostic X-ray System
Nanjing Perlove Medical Equipment Co., Ltd.The Diagnostic X-ray System is a mobile fluoroscopic X-ray system with a C-arm and digital imaging capabilities. It is used by trained medical professionals for real-time imaging guidance during diagnostic, interventional, and surgical procedures, helping clinicians visualize inside the body with X-rays from various angles.
Intended Use
The Diagnostic X-ray System is intended to be used and operated by adequately trained health care professionals for radiological guidance and visualization during diagnostic, interventional, and surgical procedures on all patients except neonates, in various clinical settings including sterile and non-sterile environments.
Technology
The system uses a C-arm design with an X-ray source, collimator, flat-panel detector, and image processing workstation. X-rays pass through the patient, are detected by a flat panel detector, converted into images, and displayed on monitors. The C-arm enables imaging from various angles with digital image manipulation.
Performance
Performance data includes electrical safety and electromagnetic compatibility testing, bench testing of imaging metrics comparing to predicate device, clinical imaging reviewed by a radiologist, software verification and validation, cybersecurity documentation, usability validation, and biocompatibility testing. No clinical study was included, and results demonstrate safety and effectiveness comparable to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/1/2024
6 months - 2
FDA Approval
5/19/2025
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