510(k) · Cleared
ClearedThermPix Thermovisual Camera
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usa Therm, Inc. · LHQ System, Telethermographic (Adjunctive Use)
Cleared on Sep 14, 2023 as substantially equivalent to K213650 (Usa Therm, Inc., 2022) after a 30-day review. Its family tree reaches back 4 generations to 2006.
- Decided
- Sep 14, 2023
- Review
- 30 days
- Class
- Class I
- Product code
- LHQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K063047 (2006). No later device cites it as a predicate yet.
- Root · 4 generations backK063047 Medhot Mti 2000 Thermal Imaging SystemMedhot Thermal Imaging, Inc. · 2006 · Recalled
- 3 generations backK171928 Med-Hot Thermal Imaging SystemsMed-Hot Thermal Imaging, Inc. · 2017
- 2 generations backK181716 InTouch Thermal CameraIntouch Technologies, Inc., D.B.A. Intouch Health · 2019
- 1 generation backK213650 ThermPix Thermovisual CameraUsa Therm, Inc. · 2022
- This deviceK232462 ThermPix Thermovisual CameraUsa Therm, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K063047 | Medhot Mti 2000 Thermal Imaging System | Medhot Thermal Imaging, Inc. | 2006 | 1 |
| −3 | K171928 | Med-Hot Thermal Imaging Systems | Med-Hot Thermal Imaging, Inc. | 2017 | — |
| −2 | K181716 | InTouch Thermal Camera | Intouch Technologies, Inc., D.B.A. Intouch Health | 2019 | — |
| −1 | K213650 | ThermPix Thermovisual Camera | Usa Therm, Inc. | 2022 | — |
| 0 (this device) | K232462 | ThermPix Thermovisual Camera | Usa Therm, Inc. | 2023 | — |
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? (1)
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 |
|---|---|---|---|
| * | K213650 | ThermPix Thermovisual CameraSummary page 4…PREDICATE DEVICE Predicate Manufacturer: USA Therm, Inc. Predicate Trade Name: ThermPix Thermovisual Camera Predicate 510(k): K213650 No reference devices were used in this submission. IV. DEVICE DESCRIPTION The ThermPix Thermovisual Camera is a Telethermograph… | 2022 |
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.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All LHQ devicesLHQ System, Telethermographic (Adjunctive Use): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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 ThermPix Thermovisual Camera is intended to view, measure, and record heat patterns and variations. It is intended for use as adjunctive diagnostic imaging for thermally significant indications stemming from heat emitted from the human body. The significance of these thermal patterns and variations is determined by professional investigation. This device is intended for use by qualified technical personnel. Clinical judgement and experience are…
Read the full statement (123 words)
The ThermPix Thermovisual Camera is intended to view, measure, and record heat patterns and
variations. It is intended for use as adjunctive diagnostic imaging for thermally significant indications
stemming from heat emitted from the human body. The significance of these thermal patterns and
variations is determined by professional investigation. This device is intended for use by qualified
technical personnel. Clinical judgement and experience are required to review and interpret the
information transmitted.
The ThermPix Thermovisual Camera is only for use in addition to other diagnostic medical devices.
It does not provide any absolute measurement of temperature and should not be used for sole
screening or diagnosis for any disease or condition.
The system is not intended to be used as a thermometry device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232462: ThermPix Thermovisual Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232462
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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