Australian firm Micro-X has completed final compliance testing of its Rover mobile x-ray unit for deployed military hospitals, according to a report published June 1 by the Lead South Australia.
Micro-X's Rover military x-ray unit has completed final testing in Australia. Image courtesy of Micro-X.The testing is the company's final step before applying for 510(k) clearance for the device from the U.S. Food and Drug Administration (FDA). Once it receives this clearance, it will be available for the U.S. Army Medical Materiel Agency, the Lead report said.
Micro-X also plans to file European and Australian regulatory approval applications for Rover.
The company is the manufacturer of DRX Revolution Nano, which is distributed in the U.S. by Carestream Health, according to the Lead.
