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.
An external, hand-held, electronic listening device designed to be used by a healthcare professional for real-time detection and amplification of body sounds (e.g., heart, blood vessels, lungs) that may be difficult to perceive when using a mechanical stethoscope; it is not designed for electrocardiography (ECG). It is typically designed to be connected to a computing device, which may operate interpretive software sometimes provided with the stethoscope, for recording and/or displaying the results in the form of a graph [phonocardiogram (PCG)].