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510(k) Data Aggregation
K Number
K033967Device Name
TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P
Manufacturer
FLIR SYSTEMS
Date Cleared
2004-03-09
(78 days)
Product Code
LHQ
Regulation Number
884.2980Why did this record match?
Applicant Name (Manufacturer) :
FLIR SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flir devices are intended for use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of differences in skin surface temperature changes. It can visualize, document temperature patterns and changes. Environment of use: hospital, sub-acute, public areas, i.e., airports
Device Description
Flir manufactures a number of IR camera's, they all include the same basis temperature measurement and sensing technology. They are non-contacting and employ passive infrared emissions for sensing temperature variations.
The captured energy is processed by software to produce digital output values of the thermal energy captured by the camera's thermal sensors.
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