DeviceClearance

Product code SHL— Ear, Nose, Throat

Tyto Insights for Eardrum Bulging Detection

Classification name
Ear, Nose, And Throat Image Analyzer
Device class
Class 2
Regulation
21 CFR 874.4775
Advisory panel
Ear, Nose, Throat
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code SHL under 21 CFR 874.4775, via openFDA

Market context for product code SHL

FDA has cleared 1 device under product code SHL, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SHL

Recent clearances under product code SHL

Data sourced from openFDA. This site is unofficial and independent of the FDA.