Hello,
I have noticed that 510(k) A.I devices as below
I think diagnostic softwares(Prostate Mr, Brain Mr) seem A.I analytic algorithm and they are operating as a module under image managing software(Engine).
I know that software alone is considered as medical device(SaMD) in FDA but I wonder A.I algorithm is also considered as a medical device.
My view is
A.I algorithm can't operate alone. It must be operating with image managing software.
Then it should be considered as component of image managing software.
Does A.I algorithm diagnostic software alone is considered as medical device?
I have noticed that 510(k) A.I devices as below
I think diagnostic softwares(Prostate Mr, Brain Mr) seem A.I analytic algorithm and they are operating as a module under image managing software(Engine).
I know that software alone is considered as medical device(SaMD) in FDA but I wonder A.I algorithm is also considered as a medical device.
My view is
A.I algorithm can't operate alone. It must be operating with image managing software.
Then it should be considered as component of image managing software.
Does A.I algorithm diagnostic software alone is considered as medical device?