FETOLY
K251368Diagnoly · cleared 2025-09-12 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“Fetoly is a software that aims at helping sonographers, obstetricians, radiologists, maternal-fetal medicine specialists and pediatric cardiologists (designated as healthcare professionals i.e. HCPs) to perform fetal ultrasound examinations of the fetal brain and heart in real-time.”
source quote (p.6)
“The software's frozen deep learning algorithm, which was trained by supervised learning, analyzes images of this ultrasound image stream to detect brain/heart views, quality criteria within those views and to make biometric measurements of the heart and brain.”
source quote (p.16)
“The PCCP does not include the implementation of adaptive algorithms that will continuously learn in the field.”
source quote (p.2)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
source quote (p.16)
“Cybersecurity verification and penetration testing”
Validation studies (2)
Retrospective clinical
n=750 cases · 7 site(s)
endpoints: sensitivity of fetal heart and brain ultrasound views; specificity of fetal heart and brain ultrasound views; sensitivity of quality criteria within views; specificity of quality criteria within views; mean intersection over union (IoU) of bounding boxes of quality criteria
Retrospective clinical
n=441 cases · 6 site(s)
endpoints: sensitivity of fetal heart and brain ultrasound subviews; specificity of fetal heart and brain ultrasound subviews; lower and upper limits of agreement (LOA) for fetal heart and brain biometric measurements
Reported performance (10 observations)
source quote (p.18)
“mean sensitivity of 96% with a Bootstrap Cl of (0.954-0.966)”
source quote (p.18)
“mean specificity of 99.5% with a Bootstrap Cl of (0.994-0.996).”
source quote (p.18)
“mean loU of 68.1% with a Bootstrap Cl of (0.672-0.691).”
source quote (p.18)
“mean sensitivity of 94.6%% with a Bootstrap Cl of (0.939-0.952)”
source quote (p.18)
“mean specificity of 99.4% with a Bootstrap Cl of (0.994-0.995)”
source quote (p.19)
“mean sensitivity of 91.3% with a Bootstrap Cl of (0.904-0.924)”
source quote (p.19)
“mean specificity of 99.4% with a Bootstrap Cl of (0.994-0.995)”
source quote (p.19)
“mean loU of 60% with a Bootstrap Cl of (0.594-0.605).”
source quote (p.21)
“mean sensitivity of 91.8% with a Bootstrap Cl of (0.906, 0.931)”
source quote (p.21)
“mean specificity of 99.9% with a Bootstrap Cl of (0.998, 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
- 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).