EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG

The EXPD 114, EXPD 114G, EXPD 114P, and EXPD 114PG are digital flat-panel X-ray detectors designed for general radiographic imaging of human anatomy. These devices replace traditional film or screen-based X-ray systems in general diagnostic procedures and are intended for both adult and pediatric populations, excluding mammography applications.

The subject devices are indirect conversion detectors using rectangular panels measuring 460mm (W) × 1,178mm (L) × 20mm (H) with a 140µm pixel pitch and 3,072 × 8,192 image resolution. Key differences from predicate devices include variable TFT panel materials (amorphous Silicon for EXPD 114/114G and IGZO for EXPD 114P/114PG) and different scintillator options (CsI or Gadox). Performance metrics show DQE of 25-45% at 0.5 lp/mm and MTF of 40% at 2.0 lp/mm, comparable to predicate values.

Compliance confirmed with ISO 14971 (risk management), ANSI AAMI ES60601-1:2005/AMD2:2021 (electrical safety), IEC 60601-1-2:2020 (electromagnetic disturbances), IEC 60601-1-6 (usability), IEC 62304 (software lifecycle), IEC 62220-1-1 (detective quantum efficiency), and NEMA PS 3.1-3.20 (DICOM). Firmware validation, verification, and cybersecurity testing were also performed per FDA guidance.

Substantial equivalence is demonstrated through identical intended use (general radiographic diagnosis excluding mammography), same classification (Class II stationary X-ray system, 21 CFR 892.1680), identical operating principles (indirect conversion flat-panel detection), and equivalent performance metrics (resolution and communication methods). Non-clinical bench testing showed DQE and MTF comparable to predicate K223124, and a clinical concurrence study confirmed image quality equivalence across multiple anatomical sites, with dimensional and material variations representing minor design optimizations rather than functional changes.