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510(k) Data Aggregation

    K Number
    K252089

    Validate with FDA (Live)

    Device Name
    Tyto Stethoscope (G3)
    Manufacturer
    Tyto Care , Ltd.
    Date Cleared
    2026-03-12

    (253 days)

    Product Code
    DQD
    Regulation Number
    870.1875
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K220766,K181612
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient at a different location on the IP network with the signal carried on an IP connection between the two locations. The Tyto Stethoscope is intended to be used by lay users in non-clinical environments to capture auscultation sounds for transmission to a clinician for review. The Tyto Stethoscope is for medical diagnostics purposes only. The Tyto Stethoscope is not intended for self-diagnosis.

    Device Description

    The Tyto Stethoscope (G3) system is designed for use by lay users in non-clinical environments to capture auscultation sounds for transmission to a clinician for review. It enables three types of stethoscope exams: Heart, Lungs and Heart Rate.

    The Tyto Stethoscope (G3) system is a multiple functions system, the operation process of the system uses four (4) primary functional elements:

    (1) The Tyto Stethoscope (composed of a TytoCare Device with Stethoscope adaptor supported with proprietary TytoCare Device App software).

    The TytoCare Device App contains device software functions.

    (2) A mobile device (e.g., a smartphone, not part of the Tyto Stethoscope device, not supplied by TytoCare, on which the proprietary TytoCare user App is running),

    The TytoCare User App contains only other software functions.

    (3) The TytoCare Server platform (composed of server hardware not part of the Tyto Stethoscope device, not supplied by TytoCare, on which the proprietary TytoCare server software is running).

    The TytoCare server software is composed of two modules:

    • TytoCare Server Software (Data Processing Software Module) – contains device software functions
    • TytoCare Server Software (Server Management Software Module) – contains other functions

    (4) A clinician receiving platform located in a clinical environment (e.g., a PC at the clinic, not part of the Tyto Stethoscope device, not supplied by TytoCare, on which the proprietary TytoCare Clinician Dashboard App is running).

    The TytoCare Clinician Dashboard App is composed of two modules:

    • TytoCare Clinician Dashboard (Exam Software Module) – contains device software functions
    • TytoCare Clinician Dashboard (Clinician software module) – contains other functions

    Two operational flows are optional for using the Tyto Stethoscope (G3): store-and-forward flow and on-line exam flow. Both flows are essentially similar and share the same fundamental steps: performing one or more measurements using the Tyto Stethoscope (G3), sending to a clinician, review of the measurements by the clinician. While in the store-and-forward flow the user can record the measurements and send the recorded data to the clinician whenever convenient for him/her, an online flow may be executed only when also the clinician is available on-line.

    AI/ML Overview

    N/A

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