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510(k) Data Aggregation
K Number
K030165Device Name
THERMATREK IRIS-IV INFRARED IMAGING SYSTEM
Manufacturer
Date Cleared
2003-04-16
(90 days)
Product Code
Regulation Number
884.2980Why did this record match?
Applicant Name (Manufacturer) :
THERMATREK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IRIS-IV Infrared Imaging System is a non-contact, non-invasive, non-radiating, thermal (infrared) imaging device intended for viewing heat patterns generated by the relative surface temperature of human heart tissue and vessels during coronary bypass surgery. Images of the exposed heart may be captured as black and white video images using a digital frame grabber and computer hard-drive. Digitally stored images may then be transferred from the hard-drive to a CD-ROM for portability.
The IRIS-IV Infrared Imaging System may be used to perform the viewing and documenting of temperature differences prior to grafting, cooling of the myocardial, and perfusion of the tissue distal to the anastomosis after grafting.
Device Description
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K Number
K982112Device Name
THERMATREK IRIS-3 INFRARED IMAGING SYSTEM
Manufacturer
Date Cleared
1998-08-20
(65 days)
Product Code
Regulation Number
884.2980Why did this record match?
Applicant Name (Manufacturer) :
THERMATREK, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IRIS-3 Infrared Imaging System is a thermal camera based imaging device intended for use during coronary bypass surgery. Thermal imaging of the exposed heart, using the IRIS-3, permits the viewing and recording of changes in tissue temperature prior to grafting, cooling of the myocardial, and perfusion of the tissue distal to the anastomosis after grafting. Recording of the temperature difference may be obtained using the videocassette recorder.
Device Description
The IRIS-3 Infrared Imaging System is a thermal camera based imaging device.
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