510(k) · Cleared
ClearedAutomated Aortic Stenosis Software (AutoAS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Cleared on Mar 27, 2026 as substantially equivalent to K201555 (Ultromics, Ltd., 2020) after a 95-day review. Its family tree reaches back 9 generations to 1991.
- Decided
- Mar 27, 2026
- Review
- 95 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 deviceK254161 Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026
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 deviceK254161 Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026
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) | K254161 | Automated Aortic Stenosis Software (AutoAS) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026 | — |
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…gnostic software for lesions suspicious of cancer Regulatory Class Class II Product Code POK Predicate Device EchoGo Pro (K201555) Ultromics Ltd Page 1 of 11 1. DEVICE DE… | 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 35 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. 2026, 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?
AutoAS is a software application intended to assist medical professionals in the assessment of moderate/severe aortic stenosis (AS). The software uses an artificial intelligence (AI) algorithm to process previously acquired two-dimensional transthoracic echocardiography (2D-TTE) images to provide a suggestion of moderate/severe aortic stenosis along with an associated confidence metric that can be a diagnostic aid to a physician in a point of care or…
Read the full statement (178 words)
AutoAS is a software application intended to assist medical professionals in the assessment of moderate/severe aortic stenosis (AS). The software uses an artificial intelligence (AI) algorithm to process previously acquired two-dimensional transthoracic echocardiography (2D-TTE) images to provide a suggestion of moderate/severe aortic stenosis along with an associated confidence metric that can be a diagnostic aid to a physician in a point of care or similar setting in determining if further evaluation is needed, including whether a full echocardiogram (2D, Doppler) needs to be performed.
The results of AutoAS are not intended to be used on a stand-alone basis for clinical decision making and are not intended to supplement or replace a full echocardiographic examination. AutoAS results, along with the obtained ultrasound images, must be reviewed by a qualified physician. The AutoAS product is not intended to be used on patients who have prosthetic valves and/or have had prior valve repair or replacement.
AutoAS software is indicated for use in adult patients and is intended to be an accessory to compatible ultrasound systems in environments where healthcare is provided.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254161: Automated Aortic Stenosis Software (AutoAS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254161
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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