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 Apr 12, 2022 as substantially equivalent to K181716 (Intouch Technologies, Inc., D.B.A. Intouch Health, 2019) after a 144-day review. Its family tree reaches back 3 generations to 2006. 1 later device descends from it.
- Decided
- Apr 12, 2022
- Review
- 144 days
- Class
- Class I
- Product code
- LHQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K063047 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK063047 Medhot Mti 2000 Thermal Imaging SystemMedhot Thermal Imaging, Inc. · 2006 · Recalled
- 2 generations backK171928 Med-Hot Thermal Imaging SystemsMed-Hot Thermal Imaging, Inc. · 2017
- 1 generation backK181716 InTouch Thermal CameraIntouch Technologies, Inc., D.B.A. Intouch Health · 2019
- This deviceK213650 ThermPix Thermovisual CameraUsa Therm, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK232462 ThermPix Thermovisual CameraUsa Therm, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K232462ThermPix Thermovisual CameraUsa Therm, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K063047 | Medhot Mti 2000 Thermal Imaging System | Medhot Thermal Imaging, Inc. | 2006 | 1 |
| −2 | K171928 | Med-Hot Thermal Imaging Systems | Med-Hot Thermal Imaging, Inc. | 2017 | — |
| −1 | K181716 | InTouch Thermal Camera | Intouch Technologies, Inc., D.B.A. Intouch Health | 2019 | — |
| 0 (this device) | K213650 | ThermPix Thermovisual Camera | Usa Therm, Inc. | 2022 | — |
| +1 | K232462 | ThermPix Thermovisual Camera | Usa Therm, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (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 |
|---|---|---|---|
| * | K181716 | InTouch Thermal CameraSummary page 4…E Predicate Manufacturer: InTouch Health Predicate Trade Name: InTouch Thermal Camera™ Predicate 510(k): K181716 No reference devices were used in this submission. IV. DEVICE DESCRIPTION The ThermPix Thermovisual Camera is a Telethermogr… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232462 | ThermPix Thermovisual Camera | 2023 | 0 |
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 16 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K232462 (Usa Therm, Inc., 2023) has gone furthest, with 0 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. 2022, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213650: 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/K213650
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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