510(k) · Cleared
ClearedFetoly
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnoly · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Sep 12, 2025 as substantially equivalent to K241380 (Diagnoly, 2024) after a 134-day review. Its family tree reaches back 26 generations to 1995.
- Decided
- Sep 12, 2025
- Review
- 134 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 26 generations to K935595 (1995). 130 ancestors in all, the oldest K863700 (1987). No later device cites it as a predicate yet.
- Root · 26 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 22 generations between
- 3 generations backK230365 Sonio DetectSonio · 2023
- 2 generations backK240406 Sonio DetectSonio · 2024
- 1 generation backK241380 Fetoly-HeartDiagnoly · 2024
- This deviceK251368 FetolyDiagnoly · 2025
Show all 26 generations
- Root · 26 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 25 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 24 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 23 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 22 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 21 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 20 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 19 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 18 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 17 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 16 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 15 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 14 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 13 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 12 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 11 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 10 generations backK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013
- 9 generations backK132913 Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013
- 8 generations backK142472 Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare · 2015
- 7 generations backK152567 Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare · 2015
- 6 generations backK160162 Voluson P6, Voluson P8GE Healthcare · 2016
- 5 generations backK180535 Voluson P6 and Voluson P8GE Healthcare · 2018 · Recalled
- 4 generations backK201828 Voluson SWIFT, Voluson SWIFT+GE Medical Systems Ultrasound and Primary Care Diagnostics · 2020
- 3 generations backK230365 Sonio DetectSonio · 2023
- 2 generations backK240406 Sonio DetectSonio · 2024
- 1 generation backK241380 Fetoly-HeartDiagnoly · 2024
- This deviceK251368 FetolyDiagnoly · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −25 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −24 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −23 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −22 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −21 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −20 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −19 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −18 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −17 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −16 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −15 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −14 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −13 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −12 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −11 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| −10 | K131267 | Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 | GE Healthcare | 2013 | — |
| −9 | K132913 | Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 | GE Healthcare | 2013 | — |
| −8 | K142472 | Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems | GE Healthcare | 2015 | — |
| −7 | K152567 | Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System | GE Healthcare | 2015 | — |
| −6 | K160162 | Voluson P6, Voluson P8 | GE Healthcare | 2016 | — |
| −5 | K180535 | Voluson P6 and Voluson P8 | GE Healthcare | 2018 | 1 |
| −4 | K201828 | Voluson SWIFT, Voluson SWIFT+ | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020 | — |
| −3 | K230365 | Sonio Detect | Sonio | 2023 | — |
| −2 | K240406 | Sonio Detect | Sonio | 2024 | — |
| −1 | K241380 | Fetoly-Heart | Diagnoly | 2024 | — |
| 0 (this device) | K251368 | Fetoly | Diagnoly | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 6 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 10 | 0 |
| 2004 | 12 | 0 |
| 2005 | 11 | 0 |
| 2006 | 7 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2014 | 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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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 |
|---|---|---|---|
| * | K241380 | Fetoly-HeartSummary page 5…IYN (Primary) IYO, QIH (secondary) 3 Predicate device identification The predicate device used for FETOLY is FETOLY-HEART (K241380). Additionally, a reference device was chosen for FETOLY based on its substantially equivalent technical characteristics of auto… | 2024 |
| † | K220358 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | 2022 |
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 30 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 33 of the 130 ancestors have a recall of any class.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
FETOLY is intended to analyze fetal ultrasound image sequences using machine learning techniques to automatically:
• detect brain and heart views and quality criteria within the views;
• detect images suitable for measuring biometric parameters of the fetal heart and brain and provide quantitative measurements of these parameters.
The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images.
FETOLY is indicated for use during routine fetal heart and brain examination of 2nd and 3rd trimester pregnancy (gestational age: from 17 to 40 weeks).
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/K251368 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251368: Fetoly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251368
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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