No image

Tyto Insights for Crackles Detection

Tyto Insights for Crackles Detection · Tyto Care Ltd

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 adultsand pediatrics (2 years and older). It automatically analyzes the acoustic signal of the lungas recorded by the FDA 510k cleared compatible Tyto Stethoscope and identifies recordingswhere a specific abnormal lung sound suggestive of “Crackle” is suspected. It is not intendedto detect other abnormal or normal lung sounds. A licensed health care professional’s adviceis required to understand the meaning of the Tyto Insights for Crackles Detection result.Healthcare providers should consider the device result in conjunction with recording andother relevant patient data.

Details

Device typeElectronic acoustic stethoscope: 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)].

FDA categoryAbnormal Breath Sound Device

Device ID07290020123008

AvailabilityOver the counter

MRI safetyLabeling does not contain MRI Safety Information

Contact

No contact is listed for this device.

Related products

Product	Model	Company	Device type
Tyto Insights for Rhonchi DetectionTyto Care LtdElectronic acoustic stethoscope	Tyto Insights for Rhonchi Detection	Tyto Care Ltd	Electronic acoustic stethoscope
ChestPalChestpal LtdElectronic acoustic stethoscope	LUS110	Chestpal Ltd	Electronic acoustic stethoscope
Littmann®3M CompanyElectronic acoustic stethoscope	3200BU	3M Company	Electronic acoustic stethoscope
Kosmos TorsoEchonous, Inc.Electronic acoustic stethoscope	P006025	Echonous, Inc.	Electronic acoustic stethoscope