510(k) · Cleared
ClearedEchoGo Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultromics, Ltd. · POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Cleared on Dec 18, 2020 as substantially equivalent to K190442 (Koios Medical, Inc., 2019) after a 191-day review. Its family tree reaches back 8 generations to 1991. 6 later devices descend from it.
- Decided
- Dec 18, 2020
- Review
- 191 days
- Class
- Class II
- Product code
- POK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K913770 (1991). 15 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 6 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 5 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 4 generations backK043216 Cadstream Version 4.0Confirma, Inc. · 2005
- 3 generations backK050846 B-Cad System, Version 1.0The Medipattern Corporation · 2005
- 2 generations backK161959 ClearView cCADClearview Diagnostics, Inc. · 2016 · Recalled
- 1 generation backK190442 Koios DS for BreastKoios Medical, Inc. · 2019
- This deviceK201555 EchoGo ProUltromics, Ltd. · 2020
- Descendant · cites it directly · 2 of its ownK242342 Fetal EchoScanBrightheart · 2024
- Descendant · 2 generations on · 1 of its ownK251071 Fetal EchoScan (v1.1)Brightheart · 2025
- Descendant · cites it directly · 0 of its ownK254161 Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK252294 Fetal EchoScan (v1.2)Brightheart · 2025
- Descendant · cites it directly · 0 of its ownK241245 EchoSolv ASEcho IQ, Ltd. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K242342Fetal EchoScanBrightheart · 2024 · cites it directly2descendants
- K251071Fetal EchoScan (v1.1)Brightheart · 2025 · 2 generations on1descendant
- K254161Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026 · cites it directly0descendants
- K252294Fetal EchoScan (v1.2)Brightheart · 2025 · 2 generations on0descendants
- K241245EchoSolv ASEcho IQ, Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −7 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −6 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −5 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −4 | K043216 | Cadstream Version 4.0 | Confirma, Inc. | 2005 | — |
| −3 | K050846 | B-Cad System, Version 1.0 | The Medipattern Corporation | 2005 | — |
| −2 | K161959 | ClearView cCAD | Clearview Diagnostics, Inc. | 2016 | 1 |
| −1 | K190442 | Koios DS for Breast | Koios Medical, Inc. | 2019 | — |
| 0 (this device) | K201555 | EchoGo Pro | Ultromics, Ltd. | 2020 | — |
| +1 | K242342 | Fetal EchoScan | Brightheart | 2024 | — |
| +2 | K251071 | Fetal EchoScan (v1.1) | Brightheart | 2025 | — |
| +1 | K254161 | Automated Aortic Stenosis Software (AutoAS) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026 | — |
| +2 | K252294 | Fetal EchoScan (v1.2) | Brightheart | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K190442 | Koios DS for BreastSummary page 5…21 CFR §892.2060 Regulatory Class: II Product Code: POK 3. Predicate Device Koios Medical, Inc. Koios DS For Breast device (K190442) The predicate device has not been subject to a design-related recall. 4. Device Description EchoGo Pro v1.0.2 is a standalone s… | 2019 |
What descends from it? (6)
4 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?
- The line of descent spans 29 years and passes through 8 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K242342 (Brightheart, 2024) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K190442.
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. 2020, 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?
EchoGo Pro v1.0.2 is a machine learning-based decision support system, indicated as an adjunct to diagnostic stress echocardiography for patients undergoing assessment for coronary artery disease (CAD). When utilized by an interpreting physician, this device provides information that may be useful in rendering an accurate diagnosis. Patient management decisions should not be made solely on the results of the EchoGo Pro v1.0.2 analysis. EchoGo Pro v1.0.2…
Read the full statement (141 words)
EchoGo Pro v1.0.2 is a machine learning-based decision support system, indicated as an adjunct to diagnostic stress echocardiography for patients undergoing assessment for coronary artery disease (CAD). When utilized by an interpreting physician, this device provides information that may be useful in rendering an accurate diagnosis. Patient management decisions should not be made solely on the results of the EchoGo Pro v1.0.2 analysis. EchoGo Pro v1.0.2 is to be used with stress echo exam protocols that contain A2C, A4C and mid-ventricular short-axis views at rest and at peak stress. EchoGo Pro v1.0.2 is not intended for the assessment of mild or moderate myocardial ischemia, or localization of coronary artery disease, or for the assessment of myocardial perfusion, myocardial viability or valve disease.
Limitations: EchoGo Pro v1.0.2 has not been validated on patients who underwent previous coronary artery bypass graft (CABG) 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/K201555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201555: EchoGo Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201555
Report an extraction error
Are you the manufacturer?
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