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510(k) Data Aggregation
K Number
K982327Device Name
INFRAMETRICS INFRACAM-MED
Manufacturer
INFRAMETRICS, INC.
Date Cleared
1998-08-18
(47 days)
Product Code
LHQ
Regulation Number
884.2980Why did this record match?
Applicant Name (Manufacturer) :
INFRAMETRICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InfraCAM-MED is a non-contact, non-invasive, non-radiating, thermal (infrared) imaging video camera intended as an adjunctive diagnostic device for viewing heat patterns generated by the relative surface temperature of human heart tissue and vessels during coronary artery bypass graft surgery. Images of the exposed heart may be captured as a black/white video image using VHS/SVHS videotape, or a black/white still image using a thermal image printer. The InfraCAM-MED Thermal Coronary Angiography imaging camera may be used to perform the following:
- Viewing and documenting temperature differences between myocardium, graft . and vessels distal to the anastomotic site generated by the injection of cold or warm fluid into the proximal end of a vein graft.
- Viewing and documenting temperature differences between myocardium, graft . and vessels distal to the anastomotic site generated by blood flow after release of the cross clamp(s) on a arterial graft.
- Viewing and documenting temperature changes to the myocardium during the . retrograde or antegrade perfusion of warm or cold cardioplegia.
Device Description
The InfraCAM-MED is a small infrared camera with integral high-resolution CRT viewfinder. It is a battery operated thermal imaging system that is completely self contained with integral TV compatible display. The InfraCAM-MED is qualified to MIL STD 810E. The camera head houses the thermal image camera. During surgery, the camera is situated outside the sterile field therefore it is not covered by a sterile drape.
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