NMPA granted innovation approval to Siemens’s X-ray computed tomography equipment on October 17, 2023.
What’s the Device
In the approval notice, NMPA says that “the product consists of a scanning frame, high-voltage generator, X-ray tube and X-ray tube components, beam limiter, photon counting detector, power distribution unit, patient holder, laser, console, image processing software, control host, and reconstruction workstation. It’s intended for routine CT examinations and supports coronary CT angiography and energy spectrum examinations.”
This product uses innovative photon counting detector technology to count the number of incident X-ray photons and measure the energy level of the photons. Compared with CT using traditional energy integrating detectors, this product has higher spatial resolution and can directly acquire energy spectrum images, which can further meet the needs of clinical imaging diagnosis.
There have been 232 innovation devices approved since 2014 when the channel was established. To get an English copy of innovation devices catalog, please email info@ChinaMedDevice.com.
We have translated the “Innovation Device Approval Procedure” for you.