Product code SHL

Device name

Ear, Nose, And Throat Image Analyzer

Medical specialty

Ear, Nose, Throat

Device class

2

Regulation number

874.4775

Review panel

EN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset