[ RadSafe ] What is the meaning of 510(k) approval process of USFDA?

[parthasarathy k s]

Friends,

I need some guidance. 


(1) What is meant by 510 (k) approval of US FDA for medical devices. 


(2) What are the limitations

There was at least one instance in which a medical device called No Touch Breast Scan (NTBS) is marketed in to India and advertised with subtle statements that it has some advantages over mammography in diagnosing breast cancer among young women. The statements highlight the "deficiencies" of mammography difficulties in diagnosis of breast cancer in hard breasts, ionizing radiation, use of compression devices etc 

I request  the list members conversant with the US FDA market approval process describe the process; I get the impression that the company is claiming too much once the device got 510(k) approval after a long "fight".

Any critique on NTBA which is based on thermography is welcome.


Regards
Paarthasarathy