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510(k) DEN250014

Tyto Insights for Eardrum Bulging Detection by Tyto Care , Ltd. — Product Code SHL

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
March 17, 2026
Date Received
April 21, 2025
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ear, Nose, And Throat Image Analyzer
Device Class
Class II
Regulation Number
874.4775
Review Panel
EN
Submission Type

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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  • K232237 — Tyto Insights for Wheeze Detection (December 13, 2023)
  • K221614 — TytoCare Lung Sounds Analyzer (February 24, 2023)
  • K190242 — Tyto Thermometer (March 27, 2019)
  • K181612 — Tyto Stethoscope (OTC) (December 17, 2018)
  • K160401 — Tyto Stethoscope (October 19, 2016)