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510(k) Data Aggregation
K Number
K222466Device Name
AirTom
Manufacturer
Bilab
Date Cleared
2023-06-30
(318 days)
Product Code
QEB
Regulation Number
868.1505Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AirTom is a non-invasive, non-radiation medical device that provides information of local impedance variations within a cross section of a patient's thorax. This information is presented to the clinician user as an adjunctive tool to other clinical information in order to support the user's assessment of variations in regional air content within a cross section of a patient's lungs.
It is intended for mechanically-ventilated patients in a professional healthcare facility, whose chest circumference is within the range of 32 ~ 130 cm.
AirTom does not measure regional ventilation of the lungs.
Device Description
AirTom is a ventilatory electrical impedance tomograph that uses several electrodes (16+1) placed around the patient's thorax to assess regional impedance variations in a lung slice (tomography). It provides only relative measurements about variations in local impedance.
AirTom estimates local impedance variations, occurring in a cross section of the thorax during a breathing cycle, which are linearly related to variations in regional air content within the lungs.
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K Number
K222897Device Name
Enlight 2100
Manufacturer
Timpel S.A.
Date Cleared
2023-03-07
(165 days)
Product Code
QEB, BZK
Regulation Number
868.1505Why did this record match?
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Matched: '868.1505'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ENLIGHT 2100 is a non-invasive, radiation free medical device that provides information from impedance variation from a cross-section of a patient's thorax. This information is presented to the clinician user as an adjunctive tool to other clinical information in order to support the user's assessment of variations in regional air content within a cross section of a patient's thorax.
ENLIGHT 2100 also provides respiratory parameters based on spirometric monitoring.
It is intended for mechanically ventilated adult and pediatric patients in a hospital setting, whose thorax perimeter is within the range of 37.5 - 134 cm.
ENLIGHT 2100 does not measure regional ventilation of the lungs
Device Description
ENLIGHT 2100 is a Ventilatory electrical impedance tomograph that uses several electrodes (usually between 16 and 32) placed around the patient's thorax to assess regional impedance variation in a lung slice (tomography). It provides a relative measurement, so it only provides information on variations in local impedance. ENLIGHT 2100 estimates Local Impedance Variation, occurring in a cross section of the thorax during a respiratory cycle, and which are linearly related to Variations in Regional Air Content within the lung.
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K Number
K211135Device Name
Enlight 2100
Manufacturer
Timpel S.A.
Date Cleared
2022-01-06
(265 days)
Product Code
QEB, OEB
Regulation Number
868.1505Why did this record match?
Search-Everything :
Matched: '868.1505'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ENLIGHT 2100 is a non-invasive, non-radiation medical device that provides information of local impedance variation within a cross-section of a patient's thorax. This information is presented to the clinician user as an adjunctive tool to other clinical information in order to support the user's assessment of variations in regional air content within a cross section of a patient's lungs.
It is intended for mechanically ventilated adult and pediatric patients in a hospital setting, whose thorax perimeter is within the range of 37.5 - 134cm.
ENLIGHT 2100 does not measure regional ventilation of the lungs.
Device Description
ENLIGHT 2100 is a Ventilatory electrical impedance tomograph that uses several electrodes (usually between 16 and 32) placed around the patient's thorax to assess regional impedance variation in a lung slice (tomography). It provides a relative measurement, so it only provides information on variations in local impedance.
ENLIGHT 2100 estimates Local Impedance Variation, occurring in a cross section of the thorax during a respiratory cycles, and which are linearly related to Variations in Regional Air Content within the lung.
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K Number
DEN170072Device Name
Enlight 1810
Manufacturer
Timpel Inc.
Date Cleared
2018-12-20
(447 days)
Product Code
QEB
Regulation Number
868.1505Why did this record match?
Search-Everything :
Matched: '868.1505'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ENLIGHT 1810 is a non-invasive, non-radiation medical device that provides information of local impedance variation within a cross-section of a patient's thorax. This information is presented to the clinician user as an adjunctive tool to other clinical information in order to support the user's assessment of variations in regional air content within a cross section of a patient's lungs.
It is intended for mechanically ventilated adult patients in a hospital setting, whose thorax perimeter is within the range of 78-122 cm.
Device Description
ENLIGHT 1810 is a non-invasive, radiation free medical device intended to provide information on the regional distribution of ventilation in a cross-sectional slice of the thorax.
As the total variation in impedance for the thorax corresponds to the total tidal volume, ENLIGHT 1810 can estimate the percentage of tidal volume in regions of interest (ROI) breath by breath, measuring the contribution of the impedance variation of that ROI to the total impedance of the lung.
Electrical impedance tomography (EIT) is a technique in which the electrical properties of tissues are estimated from surface electrode voltage measurements and used to provide information on Local Impedance Variation (LIV) within a cross section of a patient's thorax. Considerable electrical impedance variations are imposed on lung tissue by variations in the lung's air content. There is a linear relationship between the variations in air content and the percentage change in lung tissue impedance. This linear relationship is explored in Electrical Impedance Tomography, supporting its use as a tool to support the user's assessment of the variations in regional air content within a cross section of a patient's lungs.
The device may be used on adult patients undergoing either fully controlled or assisted mechanical ventilation in the ICU environment.
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