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The Tyto Insights for Rhonchi Detection is a prescription-use artificial intelligence (AI) enabled decision support software system used in the evaluation of lung sounds in adults and pediatrics (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA 510k cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of "Rhonchi" is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional's advice is required to understand the meaning of the Tyto Insights for Rhonchi Detection result. Healthcare providers should consider the device result in conjunction with recording and other relevant patient data.

The Tyto Insights for Rhonchi Detection is a web-based AI-enabled software system designed to aid in the clinical assessment of lungs auscultation sound data by analyzing recorded lung sounds to determine whether a Rhonchi is detected within the recorded sound data. The Tyto Insights for Rhonchi Detection Software is intended to process recordings from the FDA-cleared compatible Tyto Stethoscope (Tyto Stethoscope, K181612). The acquisition of the acoustic data (recordings) is carried out by a professional user in a clinical environment or by a lay- user in a non-medical environment, in compliance with the labeling of the Tyto Stethoscope. The system is composed of the following sub-systems: 1. The Tyto Insights for Rhonchi Detection Application Server (APS) communicates with the Tyto Insights for Rhonchi Detection Algorithm Server (ALS) and implements an application programming interface (API) for communication with the telehealth server. 2. The Tyto Insights for Rhonchi Detection Algorithm Server (ALS) receives an audio file as input and returns an analysis result of positive or negative regarding whether a Rhonchi was detected as output. 3. The Tyto Insights for Rhonchi Detection Web Server (WBS) provides a graphic indication whether a Rhonchi is detected in the recording. It can be utilized both in the patient and clinician side. All the software subsystems (servers and storage) are hosted in the cloud and communicate through IP network. The recordings from the compatible Tyto Stethoscope (K181612) are sent by the third-party point of care app to the clinician app through the telehealth server. The telehealth server sends the set of the lung sound recordings to the Tyto Insights for Rhonchi Detection web server using its dedicated API. The AI enabled algorithm runs automatically and returns a response for each audio file with the indication of rhonchi to the telehealth server which sends a response to both the clinician side and the patient side.

The Tyto Insights for Crackles Detection is an over-the-counter artificial intelligence (AI) enabled decision support software system used in the evaluation of lung sounds in adults and pediatrics (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA 510k cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of "Crackle" is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional’s advice is required to understand the meaning of the Tyto Insights for Crackles Detection result. Healthcare providers should consider the device result in conjunction with recording and other relevant patient data.

The Tyto Insights for Crackles Detection is a web-based (AI) enabled software system designed to aid in the clinical assessment of lungs auscultation sound data by analyzing recorded lung sounds to determine whether a Crackle is detected within the recorded sound data. The Tyto Insights for Crackles Detection Software is intended to process recordings from the FDA-cleared compatible Tyto Stethoscope (Tyto Stethoscope, K181612). The acquisition of the acoustic data (recordings) is carried out by a professional user in a clinical environment or by a lay- user in a non-medical environment, in compliance with the labeling of the Tyto Stethoscope. The system is composed of the following sub-systems: - The Tyto Insights for Crackles Detection Application Server (APS) communicates with 1. the Tyto Insights for Crackles Detection Algorithm Server (ALS) and implements an application programming interface (API) for communication with the telehealth server. - The Tyto Insights for Crackles Detection Algorithm Server (ALS) receives an audio file 2. as input and returns an analysis result of positive or negative regarding whether a Crackles was detected as output. - The Tyto Insights for Crackles Detection Web Server (WBS) provides a graphic 3. indication whether a Crackles is detected in the recording. It can be utilized both in patient and clinician side. All the software subsystems (servers and storage) are hosted in the cloud and communicate through IP network.

The Tyto Insights for Wheeze Detection is an over the-counter artificial intelligence (Al) enabled decision support software system used in the evaluation of lung sounds in adults and pediatrics (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of "Wheeze" is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional's advice is required to understand the meaning of the Tyto Insights for Wheeze Detection result. Healthcare providers should consider the device result in conjunction with recording and other relevant patient data.

The Tyto Insights for Wheeze Detection is a web-based (AI) enabled software system designed to aid in the clinical assessment of lungs auscultation sound data by analyzing recorded lung sounds to determine whether a Wheeze is detected within the recorded sound data. The Tyto Insights for Wheeze Detection Software is intended to process recordings from the FDA-cleared compatible Tyto Stethoscope (Tyto Stethoscope, K181612). The acquisition of the acoustic data (recordings) is carried out by a professional user in a clinical environment or by a lay- user in a non-medical environment, in compliance with the labeling of the Tyto Stethoscope. The system is composed of the following sub-systems: - 1. The Tyto Insights for Wheeze Detection Application Server (APS) communicates with the Tyto Insights for Wheeze Detection Algorithm Server (ALS) and implements an application programming interface (API) for communication with the telehealth server. - 2. The Tyto Insights for Wheeze Detection Algorithm Server (ALS) receives an audio file as input and returns an analysis result of positive or negative regarding whether a wheeze was detected as output. - The Tyto Insights for Wheeze Detection Web Server (WBS) provides a graphic 3. indication whether a wheeze is detected in the recording. It can be utilized both in patient and clinician side. All the software subsystems (servers and storage) are hosted in the cloud and communicate through IP network.

The TytoCare Lung Sounds Analyzer is an over-the-counter decision support software system used in the evaluation of lung sounds in adults and children (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of "Wheeze" is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional's advice is required to understand the meaning of the TytoCare Lung Sounds Analyzer result. Healthcare provider should consider the device result in conjunction with recording and other relevant patient data.

The TytoCare Lung Sounds Analyzer is a web-based software system designed to aid in the clinical assessment of lungs auscultation sound data by analyzing recorded lung sounds to determine whether a Wheeze is detected within the recorded sound data. The TytoCare Lung Sounds Analyzer Software is intended to process recordings from the FDA-cleared compatible Tyto Stethoscope (Tyto Stethoscope, K181612). The acquisition of the acoustic data (recordings) is carried out by a professional user in a clinical environment or by a lay- user in a non-medical environment, in compliance with the labeling of the Tyto Stethoscope. The system is composed of the following sub-systems: - 1. The TytoCare Lung Sounds Analyzer Application Server (APS) communicates with the TytoCare Lung Sounds Analyzer Algorithm Server (ALS) and implements an application programming interface (API) for communication with the telehealth server. - 2. The TytoCare Lung Sounds Analyzer Algorithm Server (ALS) receives an audio file as input and returns an analysis result of positive or negative regarding whether a wheeze was detected as output. - 3. The TytoCare Lung Sounds Analyzer Web Server (WBS) provides a graphic indication whether a wheeze is detected in the recording. It can be utilized both in patient and clinician side. All the software subsystems (servers and storage) are hosted in the cloud and communicate through IP network.

The Tyto Thermometer is a non - contact clinical infrared thermometer intent determination of human body temperature from the center of the forehead on people of all ages. The Tyto Thermometer is intended for use by both adult lay users and clinicians. It can be used both at home and in clinic environments.

The Tyto Thermometer is a non-contact infrared thermometer that enables measuring of the human body temperature for persons of all ages. The device is a hand-held infrared thermometer that, when positioned within 2 inches of a patient's forehead, measures the infrared energy emitted from the surface of the skin and converts it to a Core body temperature scale (Celsius, Fahrenheit) as represented on the oral body site. The device is designed for use by professional as well as lay users in clinical or nonclinical environments. The device can optionally be connected wirelessly to a user's mobile phone for use with a dedicated app (TytoCare App). Measurement results are displayed on the device LCD screen and in parallel on the mobile phone. Results of temperature recordings can be stored on the Tyto Server.

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 on site or 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 professional users in a clinical environment or by lay users in a nonclinical environment. The device is for medical diagnostics purposes only. The device is not intended for self-diagnosis.

The Tyto Stethoscope (OTC) is designed for use by professional as well as lay users in clinical or non-clinical environments. It enables four types of stethoscope exams: Heart, Lungs, Heart Rate and Audio (Audio is for clinician only). The operation process of the Tyto Stethoscope uses four (4) primary functional elements: (1) The Tyto Stethoscope (composed of a Stethoscope Tip and a Base Unit – Tyto Device and supported with proprietary software). (2) A mobile device (e.g., a smartphone, not part of the Tyto Stethoscope device, not supplied by TytoCare, on which the proprietary TytoCare App is running), (3) The Tyto Server platform (composed of server hardware not part of the Tyto Stethoscope device, not supplied by TytoCare, on which the proprietary server software is running). (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 Clinician App is running).

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 on site or 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 for use by professional users in a clinical environment or in conjunction with patients or lay users in a non-clinical environment.

The Tyto Stethoscope is designed for use by professional as well as lay users in clinical or nonclinical environments. It enables four types of stethoscope exams: Heart, Lungs, Heart Rate and Audio (Audio is for clinician only). The operation process of the Tyto Stethoscope uses four (4) primary functional elements: - (1) The Tyto Stethoscope (composed of a Stethoscope Tip and a Base Unit and supported with proprietary software) - (2) A mobile device (e.g., a smartphone, not part of the Tyto Stethoscope device, not supplied by TytoCare, on which the proprietary TytoCare App is running), - (3) The Tyto Server platform (composed of server hardware not part of the Tyto Stethoscope device, not supplied by TytoCare, on which the proprietary server software is running) - (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 Clinician App is running). Two operational flows are optional for using the Tyto Stethoscope: 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, recording the data and sending to a clinician, review of the recorded measurements by the clinician, and user receiving a written summary from the clinician presenting his/her assessment and/or recommendations. While in the store-and-forward flow the user can perform the measurements and send the recorded data to the clinician whenever convenient for him/her, an on-line flow may be executed only when also the clinician is available on-line.