Sonio Detect (v3)

K252433

Sonio · cleared 2026-03-16 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Sonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYN MFMs and Fetal surgeons (all three designated as healthcare professionals i.e. HCP in the following) to perform their routine fetal ultrasound examinations in real-time.”
AlgorithmArtificial Intelligence
source quote (p.15)
“Sonio Detect v3 uses Artificial Intelligence and does not include lectures of biometrics and colorimetry for 3D and Doppler.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.15)
“Cybersecurity testing”

Validation studies (1)

Bench

n=22,496 images

endpoints: Automatic detection of 14 T1 fetal ultrasound images; Automatic detection of 40 T2/T3 fetal ultrasound images; Automatic localization of 1 view (T1); Automatic detection of 1 fetal brain anatomical structure on the view "Transthalamic" at T1; Automatic detection of 7 fetal brain anatomical structures on the views “Transthalamic", “Transventricular”, “Transcerebellar" at T2/T3; Automatic detection of 8 fetal thorax and heart anatomical structures on the views "4 chambers", "LVOT”, “RVOT”, “Three vessels”, “Three vessels and trachea", "Abdominal Circumference”, “Axial view of the kidneys”, “Diaphragm”, “Abdominal cord insertion" at T1; Automatic detection of 24 fetal thorax and heart anatomical structures on the views "Four chambers", "LVOT”, “RVOT”, “Three vessels”, “Three vessels and trachea", "Abdominal Circumference”, “Axial view of the kidneys”, “Diaphragm”, “Abdominal cord insertion" at T2/T3; Automatic detection of 3 fetal placenta anatomical structures on the view “Placenta / Cervix" at T2/T3; Automatic detection of 6 fetal Sagittal Fetus anatomical structures on the views “Crown Rump Length", "Profile" at T1; Automatic detection of 1 fetal Sagittal Fetus anatomical structures on the views "Profile" at T2/T3; Automatic detection of 5 fetal Coronal Face anatomical structures on the views "Lips and nose", "Orbits”, “Coronal face" at T2/T3; Automatic detection of 3 fetal Spine anatomical structures on the view "Sagittal Spine" at T2/T3; Automatic localization of 1 brain anatomical structures (on T1); Automatic localization of 3 thorax and heart anatomical structures (on T1); Automatic detection of the Anterior placenta location for the view “Placenta / Cervix" at T2/T3; Automatic detection of the Posterior placenta location for the views “Placenta / Cervix"at T2/T3; Automatic detection of the "Female sex" for fetal sex for the view "External Genitalia" at T2/T3; Automatic detection of the "Male sex" for fetal sex for the view "External Genitalia" at T2/T3

Reported performance (30 observations)

sensitivityas written: “Automatic detection of 14 T1 fetal ultrasound images Sensitivity”0.886CI 0.876-0.898
source quote (p.17)
“0.886 (0.876-0.898)”
specificityas written: “Automatic detection of 14 T1 fetal ultrasound images Specificity”0.981CI 0.979-0.982
source quote (p.17)
“0.981 (0.979-0.982)”
sensitivityas written: “Automatic detection of 40 T2/T3 fetal ultrasound images Sensitivity”0.901CI 0.896-0.905
source quote (p.17)
“0.901 (0.896-0.905)”
specificityas written: “Automatic detection of 40 T2/T3 fetal ultrasound images Specificity”0.993CI 0.993-0.994
source quote (p.17)
“0.993 (0.993-0.994)”
sensitivityas written: “Automatic detection of 1 fetal brain anatomical structure on the view "Transthalamic" at T1 Sensitivity”0.815CI 0.751-0.871
source quote (p.17)
“0.815 (0.751-0.871)”
specificityas written: “Automatic detection of 1 fetal brain anatomical structure on the view "Transthalamic" at T1 Specificity”0.938CI 0.901-0.973
source quote (p.17)
“0.938 (0.901-0.973)”
sensitivityas written: “Automatic detection of 7 fetal brain anatomical structures on the views “Transthalamic", “Transventricular”, “Transcerebellar" at T2/T3 Sensitivity”0.941CI 0.934-0.947
source quote (p.17)
“0.941 (0.934-0.947)”
specificityas written: “Automatic detection of 7 fetal brain anatomical structures on the views “Transthalamic", “Transventricular”, “Transcerebellar" at T2/T3 Specificity”0.951CI 0.943-0.958
source quote (p.17)
“0.951 (0.943-0.958)”
sensitivityas written: “Automatic detection of 8 fetal thorax and heart anatomical structures on the views "4 chambers", "LVOT”, “RVOT”, “Three vessels”, “Three vessels and trachea", "Abdominal Circumference”, “Axial view of the kidneys”, “Diaphragm”, “Abdominal cord insertion" at T1 Sensitivity”0.872CI 0.848-0.892
source quote (p.17)
“0.872 (0.848-0.892)”
specificityas written: “Automatic detection of 8 fetal thorax and heart anatomical structures on the views "4 chambers", "LVOT”, “RVOT”, “Three vessels”, “Three vessels and trachea", "Abdominal Circumference”, “Axial view of the kidneys”, “Diaphragm”, “Abdominal cord insertion" at T1 Specificity”0.921CI 0.913-0.928
source quote (p.17)
“0.921 (0.913-0.928)”
sensitivityas written: “Automatic detection of 24 fetal thorax and heart anatomical structures on the views "Four chambers", "LVOT”, “RVOT”, “Three vessels”, “Three vessels and trachea", "Abdominal Circumference”, “Axial view of the kidneys”, “Diaphragm”, “Abdominal cord insertion" at T2/T3 Sensitivity”0.914CI 0.906-0.920
source quote (p.17)
“0.914 (0.906-0.920)”
specificityas written: “Automatic detection of 24 fetal thorax and heart anatomical structures on the views "Four chambers", "LVOT”, “RVOT”, “Three vessels”, “Three vessels and trachea", "Abdominal Circumference”, “Axial view of the kidneys”, “Diaphragm”, “Abdominal cord insertion" at T2/T3 Specificity”0.963CI 0.961-0.965
source quote (p.17)
“0.963 (0.961-0.965)”
sensitivityas written: “Automatic detection of 3 fetal placenta anatomical structures on the view “Placenta / Cervix" at T2/T3 Sensitivity”0.887CI 0.874-0.899
source quote (p.17)
“0.887 (0.874-0.899)”
specificityas written: “Automatic detection of 3 fetal placenta anatomical structures on the view “Placenta / Cervix" at T2/T3 Specificity”0.962CI 0.950-0.972
source quote (p.17)
“0.962 (0.950-0.972)”
sensitivityas written: “Automatic detection of 6 fetal Sagittal Fetus anatomical structures on the views “Crown Rump Length", "Profile" at T1 Sensitivity”0.869CI 0.849-0.896
source quote (p.18)
“0.869 (0.849-0.896)”
specificityas written: “Automatic detection of 6 fetal Sagittal Fetus anatomical structures on the views “Crown Rump Length", "Profile" at T1 Specificity”0.848CI 0.822-0.875
source quote (p.18)
“0.848 (0.822-0.875)”
sensitivityas written: “Automatic detection of 1 fetal Sagittal Fetus anatomical structures on the views "Profile" at T2/T3 Sensitivity”0.883CI 0.852-0.913
source quote (p.18)
“0.883 (0.852-0.913)”
specificityas written: “Automatic detection of 1 fetal Sagittal Fetus anatomical structures on the views "Profile" at T2/T3 Specificity”0.8CI 0.754-0.842
source quote (p.18)
“0.800 (0.754-0.842)”
sensitivityas written: “Automatic detection of 5 fetal Coronal Face anatomical structures on the views "Lips and nose", "Orbits”, “Coronal face" at T2/T3 Sensitivity”0.922CI 0.897-0.947
source quote (p.18)
“0.922 (0.897-0.947)”
specificityas written: “Automatic detection of 5 fetal Coronal Face anatomical structures on the views "Lips and nose", "Orbits”, “Coronal face" at T2/T3 Specificity”0.901CI 0.883-0.923
source quote (p.18)
“0.901 (0.883-0.923)”
sensitivityas written: “Automatic detection of 3 fetal Spine anatomical structures on the view "Sagittal Spine" at T2/T3 Sensitivity”0.839CI 0.818-0.862
source quote (p.18)
“0.839 (0.818-0.862)”
specificityas written: “Automatic detection of 3 fetal Spine anatomical structures on the view "Sagittal Spine" at T2/T3 Specificity”0.852CI 0.829-0.873
source quote (p.18)
“0.852 (0.829-0.873)”
sensitivityas written: “Automatic detection of the Anterior placenta location for the view “Placenta / Cervix" at T2/T3 Sensitivity”0.925CI 0.894-0.949
source quote (p.18)
“0.925 (0.894-0.949)”
specificityas written: “Automatic detection of the Anterior placenta location for the view “Placenta / Cervix" at T2/T3 Specificity”0.918CI 0.885-0.948
source quote (p.18)
“0.918 (0.885-0.948)”
sensitivityas written: “Automatic detection of the Posterior placenta location for the views “Placenta / Cervix"at T2/T3 Sensitivity”0.918CI 0.885-0.948
source quote (p.18)
“0.918 (0.885-0.948)”
specificityas written: “Automatic detection of the Posterior placenta location for the views “Placenta / Cervix"at T2/T3 Specificity”0.925CI 0.894-0.949
source quote (p.18)
“0.925 (0.894-0.949)”
sensitivityas written: “Automatic detection of the "Female sex" for fetal sex for the view "External Genitalia" at T2/T3 Sensitivity”1CI 1.000-1.000
source quote (p.18)
“1.000 (1.000-1.000)”
specificityas written: “Automatic detection of the "Female sex" for fetal sex for the view "External Genitalia" at T2/T3 Specificity”0.985CI 0.969-1.000
source quote (p.18)
“0.985 (0.969-1.000)”
sensitivityas written: “Automatic detection of the "Male sex" for fetal sex for the view "External Genitalia" at T2/T3 Sensitivity”0.985CI 0.969-1.000
source quote (p.18)
“0.985 (0.969-1.000)”
specificityas written: “Automatic detection of the "Male sex" for fetal sex for the view "External Genitalia" at T2/T3 Specificity”1CI 1.000-1.000
source quote (p.18)
“1.000 (1.000-1.000)”

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

85
recalls in product code, 24mo
554
MAUDE reports in code, 12mo
+85%
vs code's own 3-yr baseline
4
drift signals on this device
  • 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/K252433