510(k) · Cleared
ClearedFetal EchoScan (v1.2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brightheart · POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Cleared on Dec 8, 2025 as substantially equivalent to K251071 (Brightheart, 2025) and 1 other predicate after a 138-day review. Its family tree reaches back 11 generations to 1991.
- Decided
- Dec 8, 2025
- Review
- 138 days
- Class
- Class II
- Product code
- POK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K913770 (1991). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations between
- 3 generations backK201555 EchoGo ProUltromics, Ltd. · 2020
- 2 generations backK242342 Fetal EchoScanBrightheart · 2024
- 1 generation backK251071 Fetal EchoScan (v1.1)Brightheart · 2025
- This deviceK252294 Fetal EchoScan (v1.2)Brightheart · 2025
Show all 11 generations
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 9 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 8 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 7 generations backK043216 Cadstream Version 4.0Confirma, Inc. · 2005
- 6 generations backK050846 B-Cad System, Version 1.0The Medipattern Corporation · 2005
- 5 generations backK161959 ClearView cCADClearview Diagnostics, Inc. · 2016 · Recalled
- 4 generations backK190442 Koios DS for BreastKoios Medical, Inc. · 2019
- 3 generations backK201555 EchoGo ProUltromics, Ltd. · 2020
- 2 generations backK242342 Fetal EchoScanBrightheart · 2024
- 1 generation backK251071 Fetal EchoScan (v1.1)Brightheart · 2025
- This deviceK252294 Fetal EchoScan (v1.2)Brightheart · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −10 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −9 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −8 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −7 | K043216 | Cadstream Version 4.0 | Confirma, Inc. | 2005 | — |
| −6 | K050846 | B-Cad System, Version 1.0 | The Medipattern Corporation | 2005 | — |
| −5 | K161959 | ClearView cCAD | Clearview Diagnostics, Inc. | 2016 | 1 |
| −4 | K190442 | Koios DS for Breast | Koios Medical, Inc. | 2019 | — |
| −3 | K201555 | EchoGo Pro | Ultromics, Ltd. | 2020 | — |
| −2 | K242342 | Fetal EchoScan | Brightheart | 2024 | — |
| −1 | K251071 | Fetal EchoScan (v1.1) | Brightheart | 2025 | — |
| 0 (this device) | K252294 | Fetal EchoScan (v1.2) | Brightheart | 2025 | — |
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? (2)
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 |
|---|---|---|---|
| * | K251071 | Fetal EchoScan (v1.1)Summary page 5…er 21 CFR 892.2060 Regulatory Class: Class II Product Code: POK 3. PREDICATE DEVICE Predicate Device: Fetal EchoScan (v1.1) [K251071]. 4. DEVICE DESCRIPTION Fetal EchoScan is a cloud-based software-only device which uses neural networks to detect sus… | 2025 |
| * | K242342 | Fetal EchoScanSummary page 6…dicate Device Fetal EchoScan v1.2 Fetal EchoScan v1.1 510(k) Number K252294 K242342 Applicant BrightHeart BrightHeart Classification Regulation 892.2060… | 2024 |
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 34 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 18 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. 2025, 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?
Fetal EchoScan is a machine learning-based computer-assisted diagnosis (CADx) software device indicated as an adjunct to fetal heart ultrasound examination in pregnant women aged 18 or older undergoing second-trimester anatomic ultrasound exams. When utilized by an interpreting physician, Fetal EchoScan provides information regarding the presence of any of the following suspicious radiographic findings: - overriding artery - septal defect at the cardiac…
Read the full statement (226 words)
Fetal EchoScan is a machine learning-based computer-assisted diagnosis (CADx) software device indicated as an adjunct to fetal heart ultrasound examination in pregnant women aged 18 or older undergoing second-trimester anatomic ultrasound exams.
When utilized by an interpreting physician, Fetal EchoScan provides information regarding the presence of any of the following suspicious radiographic findings:
- overriding artery
- septal defect at the cardiac crux
- abnormal relationship of the outflow tracts
- enlarged cardiothoracic ratio
- right ventricular to left ventricular size discrepancy
- tricuspid valve to mitral valve annular size discrepancy
- pulmonary valve to aortic valve annular size discrepancy
- cardiac axis deviation
Fetal EchoScan is to be used with cardiac fetal ultrasound video clips containing interpretable 4-chamber, left ventricular outflow tract, right ventricular outflow tract standard views.
Fetal EchoScan is intended for use as a concurrent reading aid for interpreting physicians. It does not replace the role of the physician or of other diagnostic testing in the standard of care. When utilized by an interpreting physician, this device provides information that may be useful in rendering an accurate diagnosis regarding the potential presence of morphological abnormalities that might be suggestive of fetal congenital heart defects that may be useful in determining the need for additional exams.
Fetal EchoScan is not intended for use in multiple pregnancies, cases of fetal heterotaxy and postnatal ultrasound exams.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252294 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252294: Fetal EchoScan (v1.2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252294
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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