510(k) · Cleared
ClearedAlfaSight 9000 Thermographic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Thermodiagnostics, Inc. · LHQ System, Telethermographic (Adjunctive Use)
Cleared on Apr 10, 2015 as substantially equivalent to K971956 (Werner Eidam Medizin-Technologie GmbH, 1997) after a 49-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- Apr 10, 2015
- Review
- 49 days
- Class
- Class I
- Product code
- LHQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971956 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK971956 CRT2000 Thermographic SystemWerner Eidam Medizin-Technologie GmbH · 1997
- This deviceK150457 AlfaSight 9000 Thermographic SystemAlfa Thermodiagnostics, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK181643 SmartBag (SmartPouch)11 Health Technologies Limited · 2018
Most influential descendants
Showing 1 of 1 · See all- K181643SmartBag (SmartPouch)11 Health Technologies Limited · 2018 · cites it directly0descendants
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) | K150457 | AlfaSight 9000 Thermographic System | Alfa Thermodiagnostics, Inc. | 2015 | — |
| +1 | K181643 | SmartBag (SmartPouch) | 11 Health Technologies Limited | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K971956 | CRT2000 Thermographic SystemSummary page 4….F.R. § 884.2980 (adjunctive use) Product Code LHQ Review Panel Obstetrics/Gynecology PREDICATE DEVICE Eidam’s CRT 2000 (K971956) INTENDED USE The AlfaSight 9000 is intended for the adjunct diagnosis of: 1) abnormalities of… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181643 | SmartBag (SmartPouch) | 2018 | 0 |
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?
How does its category compare?
All LHQ devicesLHQ System, Telethermographic (Adjunctive Use): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 AlfaSight 9000 is intended for the adjunct diagnosis of: 1) abnormalities of the female breast; 2) peripheral vascular disease; 3) musculoskeletal disorders; 4) extracranial cerebral and facial vascular disease; 5) abnormalities of the thyroid gland; and 6) various neoplastic and inflammatory conditions.
The AlfaSight 9000 is not intended to serve as a sole diagnostic screening procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150457: AlfaSight 9000 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/K150457
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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