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

edmond0033 at comcast.net edmond0033 at comcast.net
Mon Nov 19 18:28:06 CST 2012

I will get back to you tomorrow on what a 510(k) means.

Ed Baratta

edmond0033 at comcast.net

-----Original Message----- 
From: parthasarathy k s
Sent: Friday, November 16, 2012 1:12 AM
To: The International Radiation Protection( Health Physics) Mailing List
Subject: [ RadSafe ] What is the meaning of 510(k) approval process of 


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.

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