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Approved by the State Food and Drug Administration
Produced by Siemens Healthineers GmbH
X-ray computed tomography equipment
Application for registration of innovative products
X-ray computed tomography equipment
The product consists of a scanning frame, a high-voltage generator, an X-ray tube and an X-ray tube assembly, a beam limiter, a photon counting detector, a power distribution unit, a patient stand, a laser, a console, an image processing software, a control host, and a reconstruction workstation for routine CT examination, supporting coronary CT angiography and energy spectroscopy.
The product uses innovative photon counting detector technology to count the number of incident X-ray photons and measure the energy level of the photon. Compared with CT using traditional energy integration detectors, this product has higher spatial resolution and can directly acquire spectral images, which can further meet the needs of clinical imaging diagnosis.
It is reported that up to now, the State Food and Drug Administration has approved a total of 232 innovative medical devices. The drug administration department will strengthen the post-marketing supervision of the product to protect the safety of patients.
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