510(k) · Cleared
ClearedTelethermographic Camera, Series a, E, S and P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flir Systems · LHQ System, Telethermographic (Adjunctive Use)
Cleared on Mar 9, 2004 as substantially equivalent to K982327 (Inframetrics, Inc., 1998) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- Mar 9, 2004
- Review
- 78 days
- Class
- Class I
- Product code
- LHQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K951806 (1995). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK951806 Opgal Intraoperative Vascular Angiography System (Iva-2000)Opgal Optronic Industries · 1995
- 1 generation backK982327 Inframetrics Infracam-MedInframetrics, Inc. · 1998
- This deviceK033967 Telethermographic Camera, Series a, E, S and PFlir Systems · 2004
- Descendant · cites it directly · 0 of its ownK101641 AG Thermographic Camera, Model Atir-M301Ag Digital Technology Corp. · 2011
- Descendant · cites it directly · 0 of its ownK073581 Ici P and S Series IR CamerasTexas Infrared · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951806 | Opgal Intraoperative Vascular Angiography System (Iva-2000) | Opgal Optronic Industries | 1995 | — |
| −1 | K982327 | Inframetrics Infracam-Med | Inframetrics, Inc. | 1998 | — |
| 0 (this device) | K033967 | Telethermographic Camera, Series a, E, S and P | Flir Systems | 2004 | — |
| +1 | K101641 | AG Thermographic Camera, Model Atir-M301 | Ag Digital Technology Corp. | 2011 | — |
| +1 | K073581 | Ici P and S Series IR Cameras | Texas Infrared | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K982327 | Inframetrics Infracam-MedSummary page 1…junctive use) Predicate Devices: Technology Infrarnetrics, Inc. Infracam-iMed - K982327' Indications of Use Dorex, Inc.… | 1998 |
| * | K023434 | Dorex Spectrum 9000MB Thermography SystemSummary page 1…- K982327' Indications of Use Dorex, Inc. Spectrum 9000ob - K023434 Device Description: Flir manufactures a number of IR camera's, they all include the… | 2002 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K101641 (Ag Digital Technology Corp., 2011) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K982327.
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 Flir devices are intended for use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of differences in skin surface temperature changes. It can visualize, document temperature patterns and changes.
Environment of use: hospital, sub-acute, public areas, i.e., airports
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033967 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033967: Telethermographic Camera, Series a, E, S and P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033967
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026