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510(k) Data Aggregation
K Number
K232462Device Name
ThermPix Thermovisual Camera
Manufacturer
USA Therm, Inc.
Date Cleared
2023-09-14
(30 days)
Product Code
LHQ
Regulation Number
884.2980Why did this record match?
Applicant Name (Manufacturer) :
USA Therm, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ThermPix Thermovisual Camera is intended to view, measure, and record heat patterns and variations. It is intended for use as adjunctive diagnostic imaging for thermally significant indications stemming from heat emitted from the human body. The significance of these thermal patterns and variations is determined by professional investigation. This device is intended for use by qualified technical personnel. Clinical judgement and experience are required to review and interpret the information transmitted.
The ThermPix Thermovisual Camera is only for use in addition to other diagnostic medical devices. It does not provide any absolute measurement of temperature and should not be used for sole screening or diagnosis for any disease or condition.
The system is not intended to be used as a thermometry device.
Device Description
The ThermPix Thermovisual Camera is a Telethermographic system which consists of an infrared camera embedded in a Tablet case and a Commercial Off the Shelf Tablet (WIFF only). It is a non-contact, non-invasive, and non-radiating infrared system capable of imaging and storing thermal patterns generated by the human body. These images along with other patient-specific data are uploaded via WIFI to the ThermPix Cloud, a secure repository where clinicians can access and augment data from a 3rd party device or computer.
It employs passive infrared emission sensing technology to capture the thermal data and uses proprietary software to display the temperature distribution pattern as an image. It is suitable for imaging adult human targets and can be used in hospitals, acute and sub-acute healthcare settings, clinics, and any environment where healthcare is provided by a healthcare professional.
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K Number
K213650Device Name
ThermPix Thermovisual Camera
Manufacturer
USA Therm, Inc.
Date Cleared
2022-04-12
(144 days)
Product Code
LHQ
Regulation Number
884.2980Why did this record match?
Applicant Name (Manufacturer) :
USA Therm, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ThermPix Thermovisual Camera is intended to view, measure, and record heat patterns and variations. It is intended for use as adjunctive diagnostic imaging for themally significant indications stemming from heat emitted from the human body. The significance of these thermal pariations is determined by professional investigation. This device is intended for use by qualified technical personnel. Clinical judgement and experience are required to review and interpret the information transmitted.
The ThermPix Thermovisual Camera is only for use in addition to other diagnostic medical devices. It does not provide any absolute measurement of temperature and should not be used for sole screening or diagnosis for any disease or condition. The system is not intended to be used as a thermometry device.
Device Description
The ThermPix Thermovisual Camera is a Telethermographic system which consists of infrared and visual cameras and a touch-screen display. It is a non-contact, non-invasive, and non-radiating infrared system capable of imaging and storing thermal patterns generated by the human body. These images along with other patient-specific data are uploaded via Wifi to the ThermPix Cloud, a secure repository where clinicians can access and augment data from a 3rd party device or computer.
It employs passive infrared emission sensing technology to capture the thermal data and uses proprietary software to display the temperature distribution pattern as an image. It is suitable for imaging adult human targets and can be used in hospitals, acute and sub-acute healthcare settings, clinics, and any environment where is provided by a healthcare professional.
Ask a Question
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