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510(k) Data Aggregation
K Number
K200999Device Name
Thermidas IR System (ThIR-A615)
Manufacturer
Thermidas Americas, Inc.
Date Cleared
2021-01-06
(265 days)
Product Code
LHQ
Regulation Number
884.2980Why did this record match?
Applicant Name (Manufacturer) :
Thermidas Americas, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Thermidas IR System is for adjunctive use in addition to other clinical diagnostic procedures for diagnostic imaging for thermally significant indications of all skin regions of the human body. The system is for reviewing and reporting of temperature patterns and changes. The significance of the value of these thermal patterns is determined by professional investigation. The system is not intended for absolute temperature measurements. The Thermidas IR system is intended for use by trained technical personnel.
Device Description
The Thermidas IR System consists of an off-the-shelf thermal imaging camera, a mount for the camera and a Windows workstation running the Thermidas Imager software. The Thermidas IR System is a non-invasive medical device which uses infrared radiation naturally emitted by the patient, which senses variations in temperature. The captured data is processed by software producing a quantitative image on the computer screen. The medical professional can use the image to review, analyze, investigate, and quantify the temperature of the objects that are imaged.
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