# K030165: Thermatrek Iris-IV Infrared Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Thermatrek
- Decided: Apr 16, 2003 after 90 days
- Product code: LHQ (System, Telethermographic (Adjunctive Use))
- Device class: 1
- Regulation: 21 CFR 884.2980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The IRIS-IV Jnfiared 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 m y be captured as black and white video images using a digital frame grabber and computer hard-drive. Digitally stored images may then be transferred fiom the hard-drive to a CD-ROM for portability. The IRIS-IV Infiared Imaging System may be used to perform the viewing and documenting of temperature differences prior to grafting, cooling of the myocardial, and perhsion of the tissue distal to the anastomosis after grafting.

Source page: https://510kreport.com/device/K030165
Methodology: https://510kreport.com/methodology