[Edaily Reporter Shin Ha-yeon] #JPI Healthcare, a company specializing in medical imaging equipment, announced on the 18th that its digital X-ray system, “DRE Duo,” received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on the 15th.

The DRE Duo is a precision diagnostic solution that utilizes low-dose, high-quality image processing technology. It is designed to provide high-resolution images suitable for diagnosis while reducing patients’ radiation exposure.

Another key strength is its support for a streamlined workflow—from imaging to result transmission—which enhances efficiency in clinical settings. It is designed for flexible installation and operation even in space-constrained hospital environments and is equipped with a smart control system designed for user convenience, as well as dedicated software for managing image data.

The company has been participating in major global medical device exhibitions, such as RSNA, MEDICA, and WHX, to gauge local buyer demand for the DRE Duo. Having already secured global medical device companies like GE Healthcare and Siemens as clients and established a component export network in the X-ray grid sector, the company plans to diversify its overseas sales following this FDA approval.

This approval marks the company’s second FDA clearance, following the previously approved veterinary cone-beam CT (CBCT) system, “DeteCT Vet.” Building on this success, JPI Healthcare is also pursuing FDA approval for its digital tomosynthesis system, “StriXion,” by the end of this year. StriXion is currently undergoing the relevant review process.

A JPI Healthcare official stated, “Securing U.S. FDA approval for the DRE Duo just one year after its domestic launch is a significant achievement demonstrating that our diagnostic imaging technology meets global standards,” adding, “We will drive overseas sales growth in the medical imaging device sector by leveraging our lineup of digital imaging solutions, including the DRE Duo and StriXion, for which we aim to secure approval within this year.”