Is there any FDA alike Certificate for Onis ?

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aiyan
Hello,

is there any FDA alike certificate for Onis? Is it possible to be used globally from the regulation/law prospective?

Many thanks .


--aiyan
 
12/24/2010 10:56:49 AM

madric
Hi,

We have a certified version in Japan but not in US or Europe. We are now discussing with a company in USA that would like to register Onis to the FDA. This process will take some time, we will keep you inform on our website.

Regards,

 
12/27/2010 4:44:18 PM

aiyan
HI, Madric:

Is there any update regarding the registration? We are thinking to install onis globally. Please contact me via aiyanma@gmail.com.
 
1/21/2011 10:01:19 AM

madric
Hi,

Thank you for your email, we will contact you soon. Please just wait a moment.

Regards,
 
1/21/2011 11:29:08 AM

aiyan
Thanks for the response. Another email box you can reach me is aiyan.ma@ge.com.
I would like to know more about the regulation items. Please contact me..
 
1/21/2011 6:27:43 PM

aiyan
Hi,

Do yo have any ideas on which features muast have FDA certificate and which kind of featujres may not required from regulation point of view?
 
1/22/2011 12:10:25 AM

oldpapa2003
I would like to know if you have got any further on FDA 510K approval or compliance.

My company is looking for just that type of viewer that is FDA compliant/approved.

W little
 
4/28/2011 2:54:28 AM
 
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