Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)

The Lux HD 35 and Lux HD 43 Detectors are digital flat-panel X-ray imaging devices designed to convert X-rays to digital images for general radiographic diagnosis in both adult and pediatric patients. They replace traditional film/screen systems in general-purpose diagnostic procedures but are not intended for mammography or dental applications.

Both models use a TFT/photodiode array with CsI scintillator, 100 μm pixel size, and 16-bit ADC digitization. The Lux HD 35 has a 350×430 mm active area (3500×4300 pixels) while the Lux HD 43 has a 426.7×426.7 mm active area (4267×4267 pixels). Both achieve 5.0 lp/mm spatial resolution and 0.54 DQE at 1 lp/mm. They support wireless or wired operation, with improved IP67 rating and enhanced local load tolerance (150 kg) compared to the predicate device.

IEC/ES 60601-1 for electrical, mechanical, and environmental safety; IEC 60601-1-2 for EMC testing; ANSI IEEE C63.27-2017 for wireless functionality and coexistence; FDA guidance on solid-state X-ray imaging devices and cybersecurity in medical devices.

The proposed devices share identical intended use, fundamental technology, and regulatory classification with the Focus HD 43 predicate (K213529). Non-clinical performance (spatial resolution, DQE, safety, EMC) is substantially equivalent. Clinical considerations remain the same, with no negative changes in imaging performance. The Lux HD 35 represents a size variation using the same technology platform, while the Lux HD 43 matches the predicate's footprint with minor enhancements (IP rating, structural robustness) that do not alter safety or effectiveness.