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Here's the scenario...
Existing x-ray device with older technology receptor is 510k approved.
Existing newer technology receptor is 510k approved.
The x-ray device is upgraded by replacing the older technology with the newer improved receptor.
Other than improving the image and viewing options, nothing else has changed.
Question: Is it necessary to file for a new 510k approval?
I need opinions from experts from the Cove.
Existing x-ray device with older technology receptor is 510k approved.
Existing newer technology receptor is 510k approved.
The x-ray device is upgraded by replacing the older technology with the newer improved receptor.
Other than improving the image and viewing options, nothing else has changed.
Question: Is it necessary to file for a new 510k approval?
I need opinions from experts from the Cove.