510(k) · Cleared
ClearedCRT2000 Thermographic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Werner Eidam Medizin-Technologie GmbH · LHQ System, Telethermographic (Adjunctive Use)
Cleared on Aug 22, 1997 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Aug 22, 1997
- Review
- 87 days
- Class
- Class I
- Product code
- LHQ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK971956 CRT2000 Thermographic SystemWerner Eidam Medizin-Technologie GmbH · 1997
- Descendant · cites it directly · 1 of its ownK150457 AlfaSight 9000 Thermographic SystemAlfa Thermodiagnostics, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK181643 SmartBag (SmartPouch)11 Health Technologies Limited · 2018
- Descendant · cites it directly · 0 of its ownK050239 Emd Thermography SystemEm Diagnostics, Inc. · 2006
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971956 | CRT2000 Thermographic System | Werner Eidam Medizin-Technologie GmbH | 1997 | — |
| +1 | K150457 | AlfaSight 9000 Thermographic System | Alfa Thermodiagnostics, Inc. | 2015 | — |
| +2 | K181643 | SmartBag (SmartPouch) | 11 Health Technologies Limited | 2018 | — |
| +1 | K050239 | Emd Thermography System | Em Diagnostics, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 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?
- Of its descendants, K150457 (Alfa Thermodiagnostics, Inc., 2015) has gone furthest, with 1 descendant 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.
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 | — |
https://510kreport.com/device/K971956 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971956: CRT2000 Thermographic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971956
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026