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Mammography Machine Bench Testing - FDA 510(K)

Kuldeep Singh

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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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