Hello
I am wondering if anyone can clarify for me the proper classification of a device that is :
Software Image Processing - similar to PACS
In Canada - Class II - diagnostic quality viewer with measuring
In FDA - Class II - diagnostic quality viewer
In Europe - Class I with measuring function
I am confused with the TGA classification.
Thinking it is Class I measuring, like Europe.....but auditor thinks it may be Class IIa.
Any help would be great!!
I am wondering if anyone can clarify for me the proper classification of a device that is :
Software Image Processing - similar to PACS
In Canada - Class II - diagnostic quality viewer with measuring
In FDA - Class II - diagnostic quality viewer
In Europe - Class I with measuring function
I am confused with the TGA classification.
Thinking it is Class I measuring, like Europe.....but auditor thinks it may be Class IIa.
Any help would be great!!