510(k) · Cleared
ClearedMed-Hot Thermal Imaging Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Med-Hot Thermal Imaging, Inc. · LHQ System, Telethermographic (Adjunctive Use)
Cleared on Dec 8, 2017 as substantially equivalent to K063047 (Medhot Thermal Imaging, Inc., 2006) after a 164-day review. Its family tree reaches back 1 generation to 2006. 6 later devices descend from it.
- Decided
- Dec 8, 2017
- Review
- 164 days
- Class
- Class I
- Product code
- LHQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K063047 (2006). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK063047 Medhot Mti 2000 Thermal Imaging SystemMedhot Thermal Imaging, Inc. · 2006 · Recalled
- This deviceK171928 Med-Hot Thermal Imaging SystemsMed-Hot Thermal Imaging, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK181716 InTouch Thermal CameraIntouch Technologies, Inc., D.B.A. Intouch Health · 2019
- Descendant · 2 generations on · 1 of its ownK213650 ThermPix Thermovisual CameraUsa Therm, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK200999 Thermidas IR System (ThIR-A615)Thermidas Americas, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK253911 Derma-2Neko Health AB · 2026
- Descendant · 3 generations on · 0 of its ownK232462 ThermPix Thermovisual CameraUsa Therm, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K181716InTouch Thermal CameraIntouch Technologies, Inc., D.B.A. Intouch Health · 2019 · cites it directly2descendants
- K213650ThermPix Thermovisual CameraUsa Therm, Inc. · 2022 · 2 generations on1descendant
- K200999Thermidas IR System (ThIR-A615)Thermidas Americas, Inc. · 2021 · cites it directly1descendant
- K253911Derma-2Neko Health AB · 2026 · 2 generations on0descendants
- K232462ThermPix Thermovisual CameraUsa Therm, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K063047 | Medhot Mti 2000 Thermal Imaging System | Medhot Thermal Imaging, Inc. | 2006 | 1 |
| 0 (this device) | 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 | — |
| +2 | K213650 | ThermPix Thermovisual Camera | Usa Therm, Inc. | 2022 | — |
| +1 | K200999 | Thermidas IR System (ThIR-A615) | Thermidas Americas, Inc. | 2021 | — |
| +2 | K253911 | Derma-2 | Neko Health AB | 2026 | — |
| +3 | K232462 | ThermPix Thermovisual Camera | Usa Therm, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K063047 | Medhot Mti 2000 Thermal Imaging SystemSummary page 4…ce: Manufacturer Product Name 510(k) Number Med-Hot Thermal Imaging, Inc. MTI 2000 K063047 Device Description: The Med-Hot Thermal Imaging Systems are non-contact infrared imaging devices, with all functions controlle… | 2006 |
What descends from it? (6)
3 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?
- Its one ancestor has a recall.
- Of its descendants, K181716 (Intouch Technologies, Inc., D.B.A. Intouch Health, 2019) 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. 2017, 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 Med-Hot Thermal Imaging Systems are intended to review, measure and record skin temperature patterns and variations emitted from the human body. They are intended for use as adjunctive diagnostic imaging for thermally significant indications in the regions of the head and neck, breast, chest, abdomen, back and extremities. The significance of the value of these thermal patterns is determined by professional investigation. This device is intended for use by qualified technical personnel trained in its use.
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/K171928 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171928: Med-Hot Thermal Imaging Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171928
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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