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Some example of Class III devices from Wikipedia : > Examples of Class III devices that currently require a premarket notification include implantable pacemake
by seren 11y ago
Some example of Class III devices from Wikipedia :
> Examples of Class III devices that currently require a premarket notification include implantable pacemaker, pulse generators, HIV diagnostic tests, automated external defibrillators, and endosseous implants.[19]
I don't see how an cancer test can not be less than Class III. A misdiagnosis is potentially lethal.
- jonwachob91 11y agoA CBC (complete blood count) test is a class I...
- niels_olson 11y agoThere are also major medical training systems, for technicians and pathologists, who perform and interpret them. The devices are class 2. Putting a QBC Star in every primary care clinic improves the quality of care delivered across the board and they are designed toward sensitivity: an automated counter has to have a low threshold for abnormal, which then kicks it to a human for review. And the techs are trained to kick anything that looks like a blast to a pathologist. And it's not a one-time, in the school house tid-bit of education: every time they do a manual diff, they can't get from their cell counts to the signature block without acknowledging they need to show blasts to a pathologist.