Sonio Detect
K230365Sonio · cleared 2023-07-25 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“Sonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYNs, MFMs and Fetal surgeons (all three designated as healthcare professionals i.e. HCP) to perform their routine fetal ultrasound examinations in real-time.”
source quote (p.9)
“Sonio Detect algorithm technology is based on Artificial Intelligence, Lecture of biometrics on the image and Colorimetry identification for 3D and Doppler while the Predicate SonoLyst's algorithm technology is only based on Artificial Intelligence;”
Validation studies (1)
Retrospective clinical
n=17,885 images · 7 site(s)
endpoints: Automatically detects 3D fetal ultrasound images with high sensitivity; Automatically detects Doppler fetal ultrasound images with high sensitivity; Automatically detects fetal ultrasound views through reading of annotations on images with high proportions of annotations read correctly; Automatically detects some T1 fetal ultrasound views with high sensitivity; Automatically detects some T2/T3 fetal ultrasound views with high sensitivity; Automatically detects some fetal brain anatomical structures in some T2/T3 brain views with high sensitivity and high specificity; Automatically verifies the corresponding quality criteria; Automatically detects some fetal heart anatomical structures in the some T2/T3 heart views with high sensitivity and high specificity; Automatically verifies the zoom level for some brain views with high sensitivity and high specificity
standards: FDA's Guidance for Industry and FDA Staff, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Reported performance (10 observations)
source quote (p.10)
“Automatically detects 3D fetal ultrasound images with high sensitivity (0,980; 95% Wilson's Confidence Interval: 0.930, 0.994)”
source quote (p.10)
“Automatically verifies the zoom level for some brain views with high specificity (0.906; 95% Wilson's Confidence Interval: 0.758-0.968).”
source quote (p.10)
“Automatically detects Doppler fetal ultrasound images with high sensitivity (0,963; 95% Wilson's Confidence Interval: 0.908, 0.985);”
source quote (p.10)
“Automatically detects some T1 fetal ultrasound views with high sensitivity (0,942; Point estimate).”
source quote (p.10)
“Automatically detects some T2/T3 fetal ultrasound views with high sensitivity (0,919; Point estimate).”
source quote (p.10)
“Automatically detects some fetal brain anatomical structures in some T2/T3 brain views with high sensitivity (0,857; Point estimate)”
source quote (p.10)
“and high specificity (0,963; Point estimate), and so automatically verifies the corresponding quality criteria;”
source quote (p.10)
“Automatically detects some fetal heart anatomical structures in the some T2/T3 heart views with high sensitivity (0,900; Point estimate)”
source quote (p.10)
“and high specificity (0,982; Point estimate) and so automatically verifies the corresponding quality criteria.”
source quote (p.10)
“Automatically verifies the zoom level for some brain views with high sensitivity (0.952; 95% Wilson's Confidence Interval: 0.909-0.976)”
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) K252433 (decision 2026-03-16) from Sonio for a matching device line ("Sonio Detect (v3)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K252433
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K240406 (decision 2024-04-26) from Sonio for a matching device line ("Sonio Detect") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K240406
- 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).