Dear All,
Can we replace copley controls Gradient 262PN with Performance control GA300 without any issue? what will be the cost of Both Gradient ? can we get new performance control GA300 gradient in india ?
Even if you have the capability, It is likely that when you make this change you have created a "new systems" that is no longer covered by the governing bodies registrations that the OEM has for the system. In the US it would require a new 510K be submitted in order for the new system to be used in a clinical environment. Check laws and regulations carefully before proceeding.
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Gradient Replacement AIRIS II
April 27, 2015 10:21
Dear All,
Can we replace copley controls Gradient 262PN with Performance control GA300 without any issue? what will be the cost of Both Gradient ? can we get new performance control GA300 gradient in india ?
Kindly suggest.
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Giovanni Lombardo
re: Gradient Replacement AIRIS II
April 28, 2015 09:26
Hi,
I can help you with all the solutions for Hitachi, also in the replacement of the two amplifiers ... write to assistenza@gbsmed.it
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Bruce Smith
re: Gradient Replacement AIRIS II
April 28, 2015 09:27
Even if you have the capability, It is likely that when you make this change you have created a "new systems" that is no longer covered by the governing bodies registrations that the OEM has for the system. In the US it would require a new 510K be submitted in order for the new system to be used in a clinical environment. Check laws and regulations carefully before proceeding.
to rate and post a comment