Mammography Machine Bench Testing - FDA 510(K)

Kuldeep Singh

Involved In Discussions
#1
Hi everyone,

We are preparing the FDA 510(K) traditional file for mammography machine Class II products. Can anyone suggest us about bench testing of Mammography machine, that means what type of phantom should we use to show equivalency and good image quality.

What are the factor which should we take during image comparison with previously cleared detectors. I have reading the guideline shared by FDA but not clearly understandable to me as i am new to Mammography machine and its performance testing.

Thanks in advance , your help will be appreciated
 
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Kuldeep Singh

Involved In Discussions
#2
Hi

We are just prepared the 510(K) traditional for Mammography machine having FDA product code MUE. I have been searched and found , Product code for 2D Mammography machine and 3D mammography machine is yet same (i.e MUE).

As we have two different mammography machines (2D mammography and 3D Mammography) . So I have question in my mind about submission of these two mammography machines (i.e 2D Mammography and 3D Mammography) . Is it single submission which include both the machines or it is two different submissions.

Can we use the test reports like EMC (IEC 60601-1-2) , General safety (IEC 60601-1) of Mammography 3D (Which is higly configured from Mammography 2D) for Mammography 2D machine?
 

Ronen E

Problem Solver
Staff member
Moderator
#3

Ronen E

Problem Solver
Staff member
Moderator
#5
I already read the document but didn't come to any conclusion for submission of the device (Either single or two submission). We are preferring the single submission for these two products as they have same product code.
Please send me a PM if you want me to get more involved.
 

Kuldeep Singh

Involved In Discussions
#6
Hi Everyone,

Can anyone tell us about the product code we used in FDA for Full Field Digital Mammography (FFDM) Machine. I have searched for FFDM machine and found MUE. Can we used the same product code for FFDM 3D and 2D ?
 
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