510(k) · Cleared
ClearedSonio Suspect
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonio · POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Cleared on Jun 4, 2026 as substantially equivalent to K243614 (Sonio, 2025) after a 28-day review. Its family tree reaches back 10 generations to 1991.
- Decided
- Jun 4, 2026
- Review
- 28 days
- Class
- Class II
- Product code
- POK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K913770 (1991). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations between
- 3 generations backK190442 Koios DS for BreastKoios Medical, Inc. · 2019
- 2 generations backK212616 Koios DSKoios Medical, Inc. · 2021
- 1 generation backK243614 Sonio SuspectSonio · 2025
- This deviceK261519 Sonio SuspectSonio · 2026
Show all 10 generations
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 8 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 7 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 6 generations backK043216 Cadstream Version 4.0Confirma, Inc. · 2005
- 5 generations backK050846 B-Cad System, Version 1.0The Medipattern Corporation · 2005
- 4 generations backK161959 ClearView cCADClearview Diagnostics, Inc. · 2016 · Recalled
- 3 generations backK190442 Koios DS for BreastKoios Medical, Inc. · 2019
- 2 generations backK212616 Koios DSKoios Medical, Inc. · 2021
- 1 generation backK243614 Sonio SuspectSonio · 2025
- This deviceK261519 Sonio SuspectSonio · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −9 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −8 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −7 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −6 | K043216 | Cadstream Version 4.0 | Confirma, Inc. | 2005 | — |
| −5 | K050846 | B-Cad System, Version 1.0 | The Medipattern Corporation | 2005 | — |
| −4 | K161959 | ClearView cCAD | Clearview Diagnostics, Inc. | 2016 | 1 |
| −3 | K190442 | Koios DS for Breast | Koios Medical, Inc. | 2019 | — |
| −2 | K212616 | Koios DS | Koios Medical, Inc. | 2021 | — |
| −1 | K243614 | Sonio Suspect | Sonio | 2025 | — |
| 0 (this device) | K261519 | Sonio Suspect | Sonio | 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 |
|---|---|---|---|
| * | K243614 | Sonio SuspectSummary page 5…tory Class: Class II Product Code: POK (primary) III. Predicate Device The predicate device for this Special 510(k) is Sonio Suspect, cleared under K243614. This predicate has not been subject to a design-related recall. Page 1 of 8 ===… | 2025 |
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 8 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 17 ancestors have a recall of any class.
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?
Sonio Suspect is intended to assist interpreting physicians, during or after fetal ultrasound examinations, by automatically identifying and characterizing abnormal fetal ultrasound findings on detected views, using machine learning techniques.
The device is intended for use as a concurrent reading aid on acquired images, during and/or after fetal ultrasound examinations.
The device provides information on abnormal findings that may be useful in rendering potential diagnosis.
Patient management decisions should not be made solely on the results of the Sonio Suspect analysis.
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/K261519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261519: Sonio Suspect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261519
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026