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Recently, the information released on the website of the State Food and Drug Administration shows that the innovative medical device "magnetic resonance imaging system" produced by Xingaoyi Medical Equipment Co.
, Ltd.
has been approved for listing
.
The State Food and Drug Administration also released a list of approved innovative medical device products
.
According to the list, the "Magnetic Resonance Imaging System" is the 16th innovative medical device approved this year
.
As of April 7, China has approved 150 innovative medical device products
.
According to reports, the "magnetic resonance imaging system" consists of a superconducting magnet (1.
5T), a scanning bed, a spectrometer, a radio frequency system, a gradient system, a console, an isolation transformer, a transmitting coil, a gradient coil, a respiratory gating, and a radio frequency receiving coil.
, for clinical MRI image diagnosis
.
The main innovation of this product is the use of liquid nitrogen-free superconducting magnet technology, which uses a refrigerator to conduct direct conduction cooling
.
Compared with the conventional superconducting magnetic resonance product that uses liquid nitrogen to cool the superconducting coil in the magnet, the product has the advantages of lower production and use cost, simplified magnet structure, and reduced magnet weight
.
At present, the two key technologies of the product have applied for invention patents in China and have entered the substantive examination stage
.
The State Food and Drug Administration said that the drug regulatory department will strengthen post-market supervision of the product to protect the safety of patients using the device
.
(Yan Ruoyu)
, Ltd.
has been approved for listing
.
The State Food and Drug Administration also released a list of approved innovative medical device products
.
According to the list, the "Magnetic Resonance Imaging System" is the 16th innovative medical device approved this year
.
As of April 7, China has approved 150 innovative medical device products
.
According to reports, the "magnetic resonance imaging system" consists of a superconducting magnet (1.
5T), a scanning bed, a spectrometer, a radio frequency system, a gradient system, a console, an isolation transformer, a transmitting coil, a gradient coil, a respiratory gating, and a radio frequency receiving coil.
, for clinical MRI image diagnosis
.
The main innovation of this product is the use of liquid nitrogen-free superconducting magnet technology, which uses a refrigerator to conduct direct conduction cooling
.
Compared with the conventional superconducting magnetic resonance product that uses liquid nitrogen to cool the superconducting coil in the magnet, the product has the advantages of lower production and use cost, simplified magnet structure, and reduced magnet weight
.
At present, the two key technologies of the product have applied for invention patents in China and have entered the substantive examination stage
.
The State Food and Drug Administration said that the drug regulatory department will strengthen post-market supervision of the product to protect the safety of patients using the device
.
(Yan Ruoyu)
