Home GUDID 07290020123022 Tyto Insights for Rhonchi Detection
Primary DI 07290020123022
Brand Tyto Insights for Rhonchi Detection
Company TYTO CARE LTD
Model Tyto Insights for Rhonchi Detection
Device description 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.
Published 2026-08-26
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use false Product Codes# Code, Name table Code Name PHZ Abnormal Breath Sound Device
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PHZ Abnormal Breath Sound Device Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07290020123022 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290020123022 07290020123022 7290020123022
Regulatory Flags# DUNS number 649125325 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07290020123008 Tyto Insights for Crackles Detection Tyto Insights for Crackles Detection 2024-12-23 07290016672305 TytoHome TytoHome US 900-00015-006 2019-09-03 07290016672428 TytoHome TytoHome US 900-00015-009 2020-10-10 07290016672480 TytoHome TytoHome G2 US 900-00015-004 2020-12-09 07290016672688 TytoHome TytoHome G2 US 900-00015-063 2022-05-11 07290016672756 TytoPro TytoPro G2 900-00002-062 2024-05-26 07290016672763 TytoHome TytoHome G2 US 900-00015-064 2024-05-26 07290016672886 Tyto Insights for Wheeze Detection Tyto Insights for Wheeze Detection _US 2024-05-26 07290016672725 Tyto Insights for Wheeze Detection Tyto Insights for Wheeze Detection _US 2023-05-14 07290016672541 TytoPro TytoPro G2 US 900-00002-007 2020-12-09 07290016672404 Tyto Stethoscope Tyto Stethoscope, Plastic, black, US 800-00027 2020-10-10 07290016672299 TytoPro TytoPro US 900-00002-005 2019-09-03 07290016672343 Tyto Stethoscope Tyto Stethoscope, Zamak, BLK, US 800-00019 2019-09-03 07290016672374 Tyto Stethoscope Tyto Stethoscope, Zamak, Gray, US 800-00023 2019-09-03 07290016672015 Tyto Stethoscope Tyto Stethoscope 800-00001 2016-12-22 07290016672039 TytoPro TytoPro 900-00002 2016-12-22 07290016672046 Not in use Not in use 2016-12-22 07290016672053 TytoHome TytoHome 900-00015 2018-01-04 07290016672190 Tyto Stethoscope Tyto Stethoscope 800-00008 2019-01-24 07290016672213 TytoHome TytoHome 900-00015 2019-01-24
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07290020123008 Tyto Insights for Crackles Detection TYTO CARE LTD PHZ 2024-12-23 07290016672886 Tyto Insights for Wheeze Detection TYTO CARE LTD PHZ 2024-05-26 07290016672725 Tyto Insights for Wheeze Detection TYTO CARE LTD PHZ 2023-05-14