Device type

Ear, Nose, And Throat Image Analyzer

Product code SHL · Class II · 21 CFR 874.4775 · Ear, Nose, Throat

An ear, nose, and throat image analyzer is a device that uses software to analyze patient-specific optical images of the ear, nose, and throat area. The results are provided to healthcare providers as an aid to detection, diagnosis, or monitoring of ear, nose, and throat conditions.

FDA classification database