EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP

The EXPD-N Series is a digital X-ray detector for general radiographic diagnosis of human anatomy in both adult and pediatric patients. It replaces film or screen-based radiographic systems in all general diagnostic procedures, but is not intended for mammography applications.

The subject device uses either conventional amorphous silicon (a-Si), flexible a-Si on plastic substrate, or IGZO as the TFT material, compared to the predicate's a-Si or IGZO. Pixel pitch options are 140µm (matching predicate) or newly introduced 100µm for higher resolution. The fundamental indirect conversion operating principle—converting X-rays to visible light captured by optical sensors and processed through thin film transistors—remains identical to the predicate.

Non-clinical testing included MTF (Modulation Transfer Function) and DQE (Detective Quantum Efficiency) performance evaluation compared to the predicate device. Electrical Safety and Electromagnetic Compatibility testing was performed in accordance with IEC 60601-1 and IEC 60601-1-2.

Substantial equivalence is established because: (1) both devices share identical intended use, anatomical sites, operating principle, communication method, power supply, and dynamic range; (2) modifications are limited to substrate material (plastic vs. glass for a-Si) and pixel pitch options, neither of which alters overall image performance; and (3) non-clinical testing demonstrated performance equivalency through MTF/DQE metrics, and clinical images from various anatomical sites reviewed by expert clinicians confirmed diagnostic quality comparable to the predicate.