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510(k) Data Aggregation
K Number
K073581Device Name
ICI P AND S SERIES IR CAMERAS
Manufacturer
TEXAS INFRARED
Date Cleared
2008-07-11
(204 days)
Product Code
LHQ, LHO
Regulation Number
884.2980Why did this record match?
Applicant Name (Manufacturer) :
TEXAS INFRARED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ICI Series P and S IR Cameras, which provides capture of skin surface temperature of any part of the body, and the IR Flash Software version 1.0, which provides visualization and reporting functionalities, are intended for use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature. Environment of use: hospitals, sub-acute healthcare settings, public areas, i.e., airports.
Device Description
The ICI Series P and S IR Cameras, which provides capture of skin surface temperature of any part of the body, and the IR Flash Software version 1.0, which provides visualization and reporting functionalities, are intended for use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature. Environment of use: hospitals, sub-acute healthcare settings, public areas, i.e., airport. Components of the system include: ICI P or S Series IR Camera, USB Cable, Tripp-Lite model IS250HG isolation transformer.
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