FDA Clears Portable, Cordless X-ray System

OXOS Medical announced its MC2 Portable X-ray System has achieved FDA 510(k) clearance and is now available for sale. The device is portable and cordless, allowing healthcare practitioners to simplify the process of taking X-rays in traditional and non-traditional spaces.

In addition to static imaging capabilities, MC2ʼs 9” Class detector offers Dynamic Digital Radiography (DDR) a first for a device of this size – as well as Fluoroscopy. When practitioners can quickly access accurate images, they can diagnose the patient swiftly and return them to regular activity.

Practitioners using the MC2 can take X-rays efficiently with easy training and setup, helping reduce office wait times and getting patients the care they need quicker. The deviceʼs Viewfinder allows for quick positioning and alignment of the X-ray beam, and its Patented Positioning System assists in alignment for image capture.

Most fluoroscopes and portable X-ray systems still weigh 300 pounds or more. Theyʼre challenging to maneuver, and some physicians ultimately choose to outsource X-ray needs to imaging centers. MC2ʼs lightweight, ergonomic design makes it easy to move the device to the point of need and will allow clinicians to maximize their limited space. In addition, MC2ʼs small scatter area and low radiation output can reduce the space and infrastructure needs required by larger systems.

“OXOS has focused on transforming the experience of X-ray services for both clinicians and patients,” said Evan Ruff, Co-founder and CEO at OXOS. “By expanding access to medical imaging, the MC2 moves us closer to our mission of providing radiographic diagnostics that are accessible anytime, anywhere — enhancing the reach and impact of X-ray technology both in the United States and globally.”

MC2 is the latest release from OXOS, which launched the Micro C portable X-ray device in 2021. For the last three years, this portable solution has been used by clinics and athletic departments and has also brought X-ray capabilities to previously underserved areas.

“Everything we do at OXOS is about helping providers move into a new era of imaging,” said Dr. Gregory Kolovich, Chief Medical Officer and OXOS Co-founder. “MC2 will simplify the imaging process, empowering clinicians to provide X-ray imaging using a device a fraction of the size. We canʼt wait for practices to see the difference themselves.”