Mars Bioimaging , Ltd. - FDA 510(k) Cleared Devices

Mars Bioimaging, Ltd. is a medical device company pioneering photon counting CT imaging technology. Based in Christchurch, New Zealand, the company develops advanced diagnostic imaging systems designed for point-of-care use. Their flagship system delivers high-resolution extremity imaging with spectral material detection and reduced radiation exposure.

The company has received 1 FDA 510(k) clearance from 1 total submission. Mars Bioimaging specializes in Radiology devices, with its cleared Extremity CT Imaging System representing the company's core regulatory focus. The company achieved its first FDA clearance in 2026 and remains active in regulatory submissions.

The MARS system combines photon counting detector technology with compact, mobile design for clinical environments. Key capabilities include detailed bone and tissue imaging, simultaneous identification of multiple materials in a single scan, and lower radiation dose compared to conventional CT systems. The technology addresses logistical delays and access barriers associated with centralized imaging facilities.

Explore the company's cleared device names, product codes, and detailed clearance dates in the FDA 510(k) database.

510(k) submissions have been managed by MEDIcept as regulatory consultant.