This message was posted by a user wishing to remain anonymous
Recently, I got an information that a firm markets their X-ray devices without 510(k).
The firm have device listing some parts of their X-ray system such as high voltage generator.
To operate as X-ray system, it is installed with other company's devices such as detectors and imaging software which may have 510(k).
They say it can be marketed as distributor/installer is kit assembler, even if the whole system does not have 510(k).
It is quite interesting approach.
Does anyone has similar experience?
If then, is there any regulatory risk?
Any additional requirements or consideration needs to be cared by manufacturer and distributor(kit assembler)?
Thank you in advance,