Identity
- Trade Name
- Tyto Insights for Crackles Detection FDA UDI
- Generic Name
- Electronic acoustic stethoscope FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Tyto Insights for Crackles Detection FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290020123008 FDA UDI
- 510(k) Number
- K240555 FDA UDI
- FDA Product Code
- PHZ FDA UDI
- GMDN Term
- Electronic acoustic stethoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electronic acoustic stethoscope
Tyto Insights for Crackles Detection by Tyto Care Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electronic acoustic stethoscope.
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- Adscope® — American Diagnostic Corporation · Class II
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- Eko Core Electronic Stethoscope — Eko Devices, Inc. · Class II
- Steth IO Spot — Steth IO · Class II
- 3M™ Littmann® — 3M COMPANY · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tyto Care Ltd
Sources (1)
- FDA UDI 73ea6c6f-efbc-4cae-82e3-af2b15cd9f95 34 fields · synced May 30, 2026