Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)
iRay Imaging Technology (Haining) LimitedThe Lux HD 35 Detector and Lux HD 43 Detector by iRay Imaging Technology are digital flat panel X-ray detectors designed to provide high-resolution digital radiographic imaging for adult and pediatric patients. These detectors replace traditional film/screen systems in general radiography and connect wirelessly or via wired interfaces to DR systems, aiding clinicians in capturing and processing X-ray images for diagnosis efficiently.
Intended Use
Lux HD 35 Detector and Lux HD 43 Detector are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. Not intended for mammography or dental applications.
Technology
The devices are digital flat panel detectors featuring a TFT/PD image sensor with a CsI scintillator for converting X-ray photons to visible light and then to electronic signals. The signals are processed and formed into digital images transmitted to a PC. They support single frame mode, wireless or wired communication, and use a Digital Radiographic Imaging Acquisition Software platform handling DICOM protocol for image acquisition, enhancement, and viewing.
Performance
Non-clinical testing included electrical safety and EMC testing per IEC 60601 standards, biological evaluation for patient safety, wireless functionality testing per ANSI IEEE C63.27-2017, and cybersecurity risk assessments fulfilling federal requirements. All tests met standard requirements and confirmed substantial equivalence in clinical performance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/18/2024
4 months - 2
FDA Approval
3/18/2025
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