510(k) · Cleared
ClearedDorex Spectrum 9000MB Thermography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dorex, Inc. · LHQ System, Telethermographic (Adjunctive Use)
Cleared on Nov 14, 2002 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Nov 14, 2002
- Review
- 30 days
- Class
- Class I
- Product code
- LHQ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK023434 Dorex Spectrum 9000MB Thermography SystemDorex, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK033967 Telethermographic Camera, Series a, E, S and PFlir Systems · 2004
- Descendant · 2 generations on · 0 of its ownK101641 AG Thermographic Camera, Model Atir-M301Ag Digital Technology Corp. · 2011
- Descendant · 2 generations on · 0 of its ownK073581 Ici P and S Series IR CamerasTexas Infrared · 2008
Most influential descendants
Showing 3 of 3 · See all- K033967Telethermographic Camera, Series a, E, S and PFlir Systems · 2004 · cites it directly2descendants
- K101641AG Thermographic Camera, Model Atir-M301Ag Digital Technology Corp. · 2011 · 2 generations on0descendants
- K073581Ici P and S Series IR CamerasTexas Infrared · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023434 | Dorex Spectrum 9000MB Thermography System | Dorex, Inc. | 2002 | — |
| +1 | K033967 | Telethermographic Camera, Series a, E, S and P | Flir Systems | 2004 | — |
| +2 | K101641 | AG Thermographic Camera, Model Atir-M301 | Ag Digital Technology Corp. | 2011 | — |
| +2 | K073581 | Ici P and S Series IR Cameras | Texas Infrared | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
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? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033967 | Telethermographic Camera, Series a, E, S and P | 2004 | 2 |
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?
- Of its descendants, K033967 (Flir Systems, 2004) has gone furthest, with 2 descendants of its own.
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?
Thermal Imaging is a noninvasive diagnostic technique that allows a practitioner to quantify and visualize skin surface temperature changes. The Spectrum 9000 ME3 allows the user to graphically map the body temperature and display the image on a monitor The Spectrum 9000MB will be used as an aid for diagnosis as well as to follow up therapy on such areas as orthopedics, pain management, neurology and diabetic foot care.
The intended use for the Spectrum 9000 MB is similar to what is being used currently on the Dorex DTI- 16 thermal imager. Images are captured and stored on a computer that can be used to diagnose problem areas.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023434: Dorex Spectrum 9000MB Thermography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023434
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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