Scanner, Whole Body, Nuclear
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Hunan and Jiangsu: 2 hold an FDA registration. 1 is a contract manufacturer.
- Changsha Joymed Medical Technology Ltd. Hunan, contract manufacturer
- Joymed Medical Technology(Suzhou)Co., Ltd. Jiangsu, contract manufacturer
How Is JAM Classified?
Scanner, Whole Body, Nuclear is FDA product code JAM, Class 1, 21 CFR 892.1330.
How Does It Reach the US Market?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
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