510(k) · Cleared
ClearedEchoSolv AS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Echo IQ, Ltd. · POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Cleared on Oct 4, 2024 as substantially equivalent to K201555 (Ultromics, Ltd., 2020) after a 154-day review. Its family tree reaches back 9 generations to 1991.
- Decided
- Oct 4, 2024
- Review
- 154 days
- Class
- Class II
- Product code
- POK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K913770 (1991). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations between
- 3 generations backK161959 ClearView cCADClearview Diagnostics, Inc. · 2016 · Recalled
- 2 generations backK190442 Koios DS for BreastKoios Medical, Inc. · 2019
- 1 generation backK201555 EchoGo ProUltromics, Ltd. · 2020
- This deviceK241245 EchoSolv ASEcho IQ, Ltd. · 2024
Show all 9 generations
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 7 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 6 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 5 generations backK043216 Cadstream Version 4.0Confirma, Inc. · 2005
- 4 generations backK050846 B-Cad System, Version 1.0The Medipattern Corporation · 2005
- 3 generations backK161959 ClearView cCADClearview Diagnostics, Inc. · 2016 · Recalled
- 2 generations backK190442 Koios DS for BreastKoios Medical, Inc. · 2019
- 1 generation backK201555 EchoGo ProUltromics, Ltd. · 2020
- This deviceK241245 EchoSolv ASEcho IQ, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −8 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −7 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −6 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −5 | K043216 | Cadstream Version 4.0 | Confirma, Inc. | 2005 | — |
| −4 | K050846 | B-Cad System, Version 1.0 | The Medipattern Corporation | 2005 | — |
| −3 | K161959 | ClearView cCAD | Clearview Diagnostics, Inc. | 2016 | 1 |
| −2 | K190442 | Koios DS for Breast | Koios Medical, Inc. | 2019 | — |
| −1 | K201555 | EchoGo Pro | Ultromics, Ltd. | 2020 | — |
| 0 (this device) | K241245 | EchoSolv AS | Echo IQ, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2017 | 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 POK? 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 POK device
- #1 K242342 Fetal EchoScanscore 16.7 · 9 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 |
|---|---|---|---|
| * | K201555 | EchoGo ProSummary page 5…lass Class II Product Code POK 3. PREDICATE DEVICE Device Name EchoGo Pro Manufacturer Ultromics Limited 510(k) Number K201555 1 510(K) SUMMARY 4.… | 2020 |
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 33 years and passes through 9 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 16 ancestors have a recall of any class.
- 3 other devices also cite its predicate K201555.
How does its category compare?
All POK devicesPOK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · POK
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · POK
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · POK
No recall names POK since 2007.
Adverse event reports per year · POK
1in 2021
MAUDE reports naming product code POK, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 6 | 161 | 0 | 0 |
| 2025 | 5 | 119 | 0 | 0 |
| 2026 | 5 | 155 | 0 | — |
What is it indicated for?
EchoSolv AS is a machine learning (ML) and artificial intelligence (AI) based decision support software indicated for use as an adjunct to echocardiography for assessment of severe aortic stenosis (AS). When utilized by an interpreting physician, this device provides information to facilitate rendering an accurate diagnosis of AS. Patient management decisions should not be made solely on the results of the EchoSolv AS analysis. EchoSolv AS includes both…
Read the full statement (107 words)
EchoSolv AS is a machine learning (ML) and artificial intelligence (AI) based decision support software indicated for use as an adjunct to echocardiography for assessment of severe aortic stenosis (AS).
When utilized by an interpreting physician, this device provides information to facilitate rendering an accurate diagnosis of AS. Patient management decisions should not be made solely on the results of the EchoSolv AS analysis.
EchoSolv AS includes both the algorithm based AS phenotype analysis, and the application of recognized AS clinical practice guidelines.
Limitations: EchoSolv AS is not intended for patients under the age of 18 years or those who have previously undergone aortic valve replacement surgery
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241245: EchoSolv AS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241245
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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