FETOLY-HEART
K241380Diagnoly · cleared 2024-09-11 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“Fetoly-Heart is intended to analyze fetal ultrasound image sequences using machine learning techniques to automatically detect heart views and quality criteria within the views. The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images.”
source quote (p.12)
“Artificial Intelligence: Utilizes computer vision algorithms to analyze ultrasound images and provides visualization of detected landmarks and views”
source quote (p.14)
“The PCCP does not include the implementation of adaptive algorithms that will continuously learn in the field.”
source quote (p.14)
“The PCCP in the subject device includes proposed modifications related to modifying model training hyperparameters, additional retraining with new training and validation datasets collected, and addition/removal of heart quality criteria.”
source quote (p.13)
“Cybersecurity verification testing”
Validation studies (1)
Standalone
n=2,288 images · 7 site(s)
endpoints: fetal heart ultrasound views detection sensitivity; fetal heart ultrasound views detection specificity; quality criteria within heart views detection sensitivity; quality criteria within heart views detection specificity; bounding boxes of quality criteria mean intersection over union (IoU)
Reported performance (2 observations)
source quote (p.15)
“Abdomen view 428 0.976 (0.960,0.990)”
source quote (p.15)
“1860 0.998 (0.996,1.000)”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K251368 (decision 2025-09-12) from Diagnoly for a matching device line ("FETOLY") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251368
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (Philips Ultrasound, LLC, initiated 2025-10-31): "Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97843
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (GE Medical Systems, LLC, initiated 2025-09-18): "The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinica" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97726
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No., initiated 2025-05-16): "GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previou" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:96992
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (Siemens Medical Solutions USA, Inc., initiated 2024-08-15): "If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems wi" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:95254
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).