510(k) · Cleared
ClearedAG Thermographic Camera, Model Atir-M301
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ag Digital Technology Corp. · LHQ System, Telethermographic (Adjunctive Use)
Cleared on Jun 16, 2011 as substantially equivalent to K033967 (Flir Systems, 2004) and 1 other predicate after a 371-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Jun 16, 2011
- Review
- 371 days
- Class
- Class I
- Product code
- LHQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K951806 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK951806 Opgal Intraoperative Vascular Angiography System (Iva-2000)Opgal Optronic Industries · 1995
- 2 generations backK982327 Inframetrics Infracam-MedInframetrics, Inc. · 1998
- 1 generation backK033967 Telethermographic Camera, Series a, E, S and PFlir Systems · 2004
- This deviceK101641 AG Thermographic Camera, Model Atir-M301Ag Digital Technology Corp. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951806 | Opgal Intraoperative Vascular Angiography System (Iva-2000) | Opgal Optronic Industries | 1995 | — |
| −2 | K982327 | Inframetrics Infracam-Med | Inframetrics, Inc. | 1998 | — |
| −1 | K033967 | Telethermographic Camera, Series a, E, S and P | Flir Systems | 2004 | — |
| 0 (this device) | K101641 | AG Thermographic Camera, Model Atir-M301 | Ag Digital Technology Corp. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 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 |
|---|---|---|---|
| * | K033967 | Telethermographic Camera, Series a, E, S and PSummary page 1…te Device: The predicate device is the * TELETHERMOGRAPHIC CAMERA, Model No. SERIES A, E, S AND P (K033967) marketed by FLIR SYSTEMS * TELESIS DIGITAL INFRARED THERMAL IMAGE… | 2004 |
| * | K020783 | Telesis Digital Infrared Thermal Image System, Spectrum 9000MBSummary page 1…967) marketed by FLIR SYSTEMS * TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, Model No. SPECTRUM 9000MB (K020783) marketed by TELESIS TECHNOLOGIES INC. -Intended Use: The AG Thermographic Camera… | 2002 |
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 16 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K033967.
How does its category compare?
All LHQ devicesLHQ System, Telethermographic (Adjunctive Use): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 AG Thermographic Camera(Model no.: ATIR M301) is intended
to use as an adjunct to other clinical diagnostic procedures by
quantifying differences in skin surface temperature changes. It can
visualize and digitalize body surface temperature distribution and
temperature changes. The device is intended for use by qualified
healthcare personnel trained in its use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101641 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101641: AG Thermographic Camera, Model Atir-M301.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101641
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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