510(k) · Cleared
ClearedTytron C-500IR Clinical Infrared Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Titronics Research & Development Co. · LHQ System, Telethermographic (Adjunctive Use)
Cleared on Oct 10, 2003 as substantially equivalent to K020783 (Telesis Technologies, Inc., 2002) after a 60-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Oct 10, 2003
- Review
- 60 days
- Class
- Class I
- Product code
- LHQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020783 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK020783 Telesis Digital Infrared Thermal Image System, Spectrum 9000MBTelesis Technologies, Inc. · 2002
- This deviceK032471 Tytron C-500IR Clinical Infrared Imaging SystemTitronics Research & Development Co. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020783 | Telesis Digital Infrared Thermal Image System, Spectrum 9000MB | Telesis Technologies, Inc. | 2002 | — |
| 0 (this device) | K032471 | Tytron C-500IR Clinical Infrared Imaging System | Titronics Research & Development Co. | 2003 | — |
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 |
|---|---|---|---|
| * | K020783 | Telesis Digital Infrared Thermal Image System, Spectrum 9000MB | 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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K020783.
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?
The TyTron C-500iR Clinical infrared Imaging System is intended for adjunctive hagnostic screening for the detection of breast cancer and other uses such as: peripheral vascular disease. neuromusculoskeletal disorders, extracranial cerebral and facial vascular chsease, thyroid gland abnornihties, and vaiious other neoplasfc, metabolic, and inflammatory conditions. Use of the TyTron C-SOOIR System is not. intended to be the sole dlapostic procedure for these hseases and conht,ions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032471 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032471: Tytron C-500IR Clinical Infrared Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032471
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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