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

[Kenneth Marshall]

A 510K is an FDA application form process for devices which are "similar" 
to devices that have already been approved by the US FDA. 

Its actually a bit more comprehensive than merely an application form as 
often much supporting data will need to be provided.  That is why your 
device has merit and is justifiably useful to the medical arts. 

Mammography is a very, very cautiously approached modality by the FDA, 
often requiring much attention to detail, and you will probably need to 
offer much in the way of supporting documentation demonstrating the 
quality is acceptable to the US FDA standards and quality control 
requirements. 

Ken Marshall, RRPT
Carestream Health 
Radiation & Laser Safety Officer
Phone 585-627-8523






From:   <edmond0033 at comcast.net>
To:     "parthasarathy k s" <ksparth at yahoo.co.uk>, "The International 
Radiation Protection \(Health Physics\) MailingList" 
<radsafe at health.phys.iit.edu>
Date:   11/19/2012 07:28 PM
Subject:        Re: [ RadSafe ] What is the meaning of 510(k) approval 
process of      USFDA?
Sent by:        radsafe-bounces at health.phys.iit.edu



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 
USFDA?

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
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