510(k) · Cleared
ClearedEmd Thermography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Em Diagnostics, Inc. · LHQ System, Telethermographic (Adjunctive Use)
Cleared on Mar 16, 2006 as substantially equivalent to K003130 (Sie-Med, Inc., 2001) and 1 other predicate after a 407-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Mar 16, 2006
- Review
- 407 days
- Class
- Class I
- Product code
- LHQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K971956 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK971956 CRT2000 Thermographic SystemWerner Eidam Medizin-Technologie GmbH · 1997
- This deviceK050239 Emd Thermography SystemEm Diagnostics, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971956 | CRT2000 Thermographic System | Werner Eidam Medizin-Technologie GmbH | 1997 | — |
| 0 (this device) | K050239 | Emd Thermography System | Em Diagnostics, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (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 |
|---|---|---|---|
| * | K003130 | Regutherm 952 Thermographic SystemSummary page 1…rkeen(~,fda-complianceconsultants.com Device Name Predicate Devices Proprietary EMD thermography K003 130 SIE-MED Inc. Name: system, Model RTM-01I- Regutherrn 952 RES Common Thermogr… | 2001 |
| * | K971956 | CRT2000 Thermographic SystemSummary page 1…Regutherrn 952 RES Common Thermography System Werner Eidamn. K97 1956, CRT 2000 Name Thermographic Medizin-Technologie… | 1997 |
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?
- None of the 2 ancestors has a recall.
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 EMD Thermography System, Model RTM-02-RES is an infrared spectrum thermography system used to measure, record and view thermal patterns generated by the human body. It is intended for use as an adjunct to other clinical diagnostic procedures in the screening and diagnosis of abnormalities where a physician chooses to use thermography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050239 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050239: Emd Thermography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050239
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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