Iray Imaging Technology (Haining) Limited · Class II · Cleared Oct 9, 2025
| K-number | K252911 |
| Device name | Lux HD 2530 detector (Lux HD 2530) |
| Applicant | Iray Imaging Technology (Haining) Limited |
| Product code | MQB |
| Device class | Class II |
| Decision date | Oct 9, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.1680 |
The Lux HD 2530 Detector is a digital flat panel X-ray detector designed to convert X-ray radiation into digital images for general radiographic diagnosis in both adult and pediatric patients. It replaces film/screen systems in general-purpose diagnostic procedures but is not intended for mammography or dental applications.
The device features a 25cm × 30cm active area TFT/PD image sensor with CsI scintillator, 2500×3000 pixel matrix, 100μm pixel size, 16-bit ADC digitization, 5.0 lp/mm spatial resolution, and 0.54 DQE at 1 lp/mm. It supports wireless (IEEE 802.11a/b/g/n/ac) and wired (Gigabit Ethernet) communication, operates at +5°C to +35°C, and includes AED and DEC exposure control modules.
IEC/ES 60601-1 for electrical, mechanical, and environmental safety; IEC 60601-1-2 for EMC testing; FDA guidance on biological evaluation of medical devices; ANSI IEEE C63.27-2017 for wireless functionality and coexistence; and cybersecurity testing per section 524B(b)(2) of the Federal Food, Drug, and Cosmetics Act.
The Lux HD 2530 is substantially equivalent to predicate devices Lux HD 35 and Lux HD 43 (K243556) because it maintains identical intended use, indications, classification, product code, regulation number, fundamental technology (CsI scintillator, TFT readout), and identical key performance specifications including spatial resolution, DQE, and pixel size. Only the image matrix size and effective imaging area differ due to the smaller 25cm×30cm detector footprint.
View the full FDA submission: accessdata.fda.gov