Sonio Detect

K230365

Sonio · cleared 2023-07-25 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd
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.”
AlgorithmArtificial Intelligence, Lecture of biometrics on the image and Colorimetry identification for 3D and Doppler
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”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

n=17,885 images · 7 site(s)

endpoints: detection of 3D fetal ultrasound images; detection of Doppler fetal ultrasound images; detection of fetal ultrasound views; detection of T1 fetal ultrasound views; detection of T2/T3 fetal ultrasound views; detection of fetal brain anatomical structures; detection of fetal heart anatomical structures; verification of zoom level for brain views

Reported performance (9 observations)

sensitivity0.98CI 95% Wilson's Confidence Interval: 0.930, 0.994
source quote (p.10)
“Automatically detects 3D fetal ultrasound images with high sensitivity (0,980; 95% Wilson's Confidence Interval: 0.930, 0.994)”
specificity0.982CI Point estimate
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) and high specificity (0,982; Point estimate)”
sensitivityas written: “Sensitivity for Doppler fetal ultrasound images”0.963CI 95% Wilson's Confidence Interval: 0.908, 0.985
source quote (p.10)
“Doppler fetal ultrasound images with high sensitivity (0,963; 95% Wilson's Confidence Interval: 0.908, 0.985);”
sensitivityas written: “Sensitivity for T1 fetal ultrasound views”0.942CI Point estimate
source quote (p.10)
“Automatically detects some T1 fetal ultrasound views with high sensitivity (0,942; Point estimate).”
sensitivityas written: “Sensitivity for T2/T3 fetal ultrasound views”0.919CI Point estimate
source quote (p.10)
“Automatically detects some T2/T3 fetal ultrasound views with high sensitivity (0,919; Point estimate).”
sensitivityas written: “Sensitivity for fetal brain anatomical structures”0.857CI 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)”
specificityas written: “Specificity for fetal brain anatomical structures”0.963CI Point estimate
source quote (p.10)
“high specificity (0,963; Point estimate)”
sensitivityas written: “Sensitivity for zoom level for brain views”0.952CI 95% Wilson's Confidence Interval: 0.909-0.976
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)”
specificityas written: “Specificity for zoom level for brain views”0.906CI 95% Wilson's Confidence Interval: 0.758-0.968
source quote (p.10)
“high specificity (0.906; 95% Wilson's Confidence Interval: 0.758-0.968).”

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

85
recalls in product code, 24mo
554
MAUDE reports in code, 12mo
+85%
vs code's own 3-yr baseline
6
drift signals on this device
  • 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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K230365