After GE Healthcare implemented enhancements to the OEC 9900 Elite C-arm, a fluoroscopy device that uses x-rays to reveal real-time imagery of a patient's internal structure, it filed a new 510(k) for the unit.
The 9900 Elite C-arm, the company's flagship C-arm offers a fully-motorized option designed to give the user complete control of the C-arm's lateral and orbital movements at 9 degrees per second – right from the tableside control panel with an easy-to-use joystick. A collision protection system provides both audible and visual warnings when it detects contact.
The new 510(k) unit will include an uninterruptible power supply or UPS so that if the power is suddenly cut, there is still power and the image is not lost.