X-Ray Field Indicator Light (Laser)
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Guangdong: 2 hold an FDA registration. 1 is a contract manufacturer.
- Shenzhen Joose Beauty Electronic Co., Ltd. Guangdong, contract manufacturer
- Shenzhen Shanglaite Electronic Technology Co., Ltd. Guangdong
What Is This Device?
A laser incorporated in a diagnostic x-ray system that is irradiated onto the film screen area indicating the x-radiation area. The beam is usually scanned to show a rectangular region for patient placement.
What Is FDA Product Code RGC?
X-Ray Field Indicator Light (Laser) is FDA product code RGC, Class 1, 21 CFR 892.5780.
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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