Product Code: SHL
FDA class 2
21 CFR 874.4775
Ear, Nose, And Throat Image Analyzer
Ear, Nose, Throat
510(k)s
1
FEI Numbers
1
Registration Numbers
1
Unique Applicants
1
Years Active
—
Basic Information
- Product Code
- SHL
- Device Class
- FDA class 2
- Regulation Number
- 874.4775
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
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.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN250014 | Tyto Insights for Eardrum Bulging Detection | Mar 17, 2026 | Unknown | Tyto Care , Ltd. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.