1 device · 1 company · 2026
Product code SHL: Ear, Nose, And Throat Image Analyzer
1 device under product code SHL, 2026, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Ear, Nose, And Throat Image Analyzer. 21 CFR 874.4775, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Tyto Insights for Eardrum Bulging DetectionDEN250014 · De Novo | Tyto Care , Ltd. | Ear Nose & Throat | database entry |
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