510(k) · Cleared
ClearedMark I Thermal Imager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ix-Dr, Inc. · LHQ System, Telethermographic (Adjunctive Use)
Cleared on Feb 11, 2003 after a 78-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 11, 2003
- Review
- 78 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?
Thennal Imaging is a medical imaging modality for use: as an adjuxlctive procedwe to supporc other diagmstic modalities. For example, thermal imaging of breasts c8n demonstrate a temperatute variance as a method to help cluuify findings indicated by mammography or some other duqpostic procedure. Thermal. imaging in general is a determination of physiologic rather than anatomic change. Neoangioenesis accompanies tumor growth and typically produces an…
Read the full statement (114 words)
Thennal Imaging is a medical imaging modality for use: as an adjuxlctive procedwe to supporc other diagmstic modalities. For example, thermal imaging of breasts c8n demonstrate a temperatute variance as a method to help cluuify findings indicated by mammography or some other duqpostic procedure.
Thermal. imaging in general is a determination of physiologic rather than anatomic change. Neoangioenesis accompanies tumor growth and typically produces an deration in blood vessels. Aay changes in blood vessel activity generally introduce a change in temperature in the immediaie area ofthe affected blood vessel.
Thermography is incapable of visualizing anatomic matter unless it is accompanied by an atternion in surface temperature. Hence, thermography is an adjunctive medical imaging modality.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023925 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023925: Mark I Thermal Imager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023925
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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