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Do I need FDA certificate if ONIS not used for diagnostic

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mulOMpUR

Hi,

If we only make use of the basic functions: importing, browsing and burning to DVD. And the images are not for diagnostic purpose, no DSA, no measure. In this case, shall Onis go without FDA alike certificate?

1/27/2011 11:23:38 AM

mulOMpUR

Hi,

If the images are not used for diagnostic purpose, we believe that a certified software is not required. However, we recommend you to double check this information.

Regards,

2/1/2011 12:26:58 PM