S
sorcerer
Hello All,
When I googled FDA Classification for Medical device, I got these definitions:
Class I Medical Devices are simple in design and have little to no potential risk.
Class II Medical devices are more complicated in design and pose a minimal risk. Medical devices classified as type II must follow general policy and special labeling, mandatory performance standards and post market surveillance.
I am looking at the proper classification of DICOM viewer.
One DICOM Viewer I am looking at, RemotEye, this device is listed as FDA Class 1. (Sorry, I am not allow to post a URL to this product here).
The other DICOM Viewer product, Aycan OsiriX Pro listed their device as FDA Class 2. (Again sorry, I am not allow to post a URL)
Can someone please inform me whether a DICOM viewer should be Classified Class 1 or Class 2. Suppose the viewer is for remote viewing.
Thanks in advance.
Sorcerer
When I googled FDA Classification for Medical device, I got these definitions:
Class I Medical Devices are simple in design and have little to no potential risk.
Class II Medical devices are more complicated in design and pose a minimal risk. Medical devices classified as type II must follow general policy and special labeling, mandatory performance standards and post market surveillance.
I am looking at the proper classification of DICOM viewer.
One DICOM Viewer I am looking at, RemotEye, this device is listed as FDA Class 1. (Sorry, I am not allow to post a URL to this product here).
The other DICOM Viewer product, Aycan OsiriX Pro listed their device as FDA Class 2. (Again sorry, I am not allow to post a URL)
Can someone please inform me whether a DICOM viewer should be Classified Class 1 or Class 2. Suppose the viewer is for remote viewing.
Thanks in advance.
Sorcerer