SHL — Ear, Nose, And Throat Image Analyzer Class II
FDA product code SHL covers "Ear, Nose, And Throat Image Analyzer", a Class II medical device regulated under 21 CFR 874.4775. Submissions are reviewed by the Ear, Nose, Throat panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SHL
- Device Class
- Class II
- Regulation Number
- 874.4775
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250014 | tyto care | Tyto Insights for Eardrum Bulging Detection | March 17, 2026 |