Tyto Insights for Crackles Detection

GUDID 07290020123008

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.

TYTO CARE LTD

Electronic acoustic stethoscope

• Primary Device ID: 07290020123008
• NIH Device Record Key: 73ea6c6f-efbc-4cae-82e3-af2b15cd9f95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tyto Insights for Crackles Detection
• Version Model Number: Tyto Insights for Crackles Detection
• Company DUNS: 649125325
• Company Name: TYTO CARE LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290020123008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240555

FDA Product Code

• PHZ: Abnormal Breath Sound Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-31
• Device Publish Date: 2024-12-23

Devices Manufactured by TYTO CARE LTD

• 07290020123008 - Tyto Insights for Crackles Detection: 2024-12-31The 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.
• 07290020123008 - Tyto Insights for Crackles Detection: 2024-12-31 The Tyto Insights for Crackles Detection is an over-the-counter artificial intelligence (AI) enabled decision support software s
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• 07290016672763 - TytoHome: 2024-06-03 TytoHome used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 072900166727
• 07290016672886 - Tyto Insights for Wheeze Detection: 2024-06-03 The “Tyto Insights for Wheeze Detection” is an over-the-counter artificial intelligence (AI) enabled decision support softwa
• 07290016672725 - Tyto Insights for Wheeze Detection: 2023-05-22 The Insights for Wheeze Detection is an over-the-counter decision support software system used in the evaluation of lung sounds
• 17290016672685 - TytoHome: 2022-05-19 TytoHome used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 072900166724
• 07290016672473 - Tyto Device: 2020-12-17 The Tyto Device unit contains the Tyto Exam Camera and Tyto Thermometer. It is used also as the display (UI) and operation comp
• 17290016672487 - TytoHome: 2020-12-17 TytoHome used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 072900166724