510(k) · Cleared
ClearedThermatrek Iris-IV Infrared Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermatrek · LHQ System, Telethermographic (Adjunctive Use)
Cleared on Apr 16, 2003 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 16, 2003
- Review
- 90 days
- Class
- Class I
- Product code
- LHQ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LHQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LHQ device
- #1 K253911 Derma-2score 12.0 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LHQ devicesLHQ System, Telethermographic (Adjunctive Use): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LHQ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LHQ
Too few LHQ 510(k)s in any year since 2007 to give a median.
Recalls per year · LHQ
No recall names LHQ since 2007.
Adverse event reports per year · LHQ
1in 2025
MAUDE reports naming product code LHQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (108 words)
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K030165 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030165: Thermatrek Iris-IV Infrared Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030165
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026