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Ear, Nose, And Throat Image Analyzer

FDA product code SHL · 1 cleared devices

Class 2 Ear, Nose, Throat
Regulation
21 CFR 874.4775
Review panel
EN
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2026-09-21 – 2026-09-21

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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