SHL

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Ear, Nose, And Throat Image Analyzer

Device class

Class II (moderate risk)

Regulation

21 CFR 874.4775

Medical specialty

Ear, Nose, Throat

FDA definition

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.

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