Digital Color Doppler Ultrasound System (P60 Series)

K241949

Sonoscape Medical Corp. · cleared 2025-01-17 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.9)
“The P60 Series Digital Color Doppler Ultrasound System add one new feature: S-FetusAI, which is carried out using the Artificial Intelligence or Machine Learning algorithm.”
AlgorithmArtificial Intelligence or Machine Learning algorithm
source quote (p.9)
“The P60 Series Digital Color Doppler Ultrasound System add one new feature: S-FetusAI, which is carried out using the Artificial Intelligence or Machine Learning algorithm.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Standalone

n=3,717 images · 3 site(s)

endpoints: S-Fetus-Recognition accuracy; S-fetus-Measure accuracy

Retrospective clinical

n=158 cases

endpoints: Identification Precision of the 14 Standard Sections; Measurement Error of Growth Parameters; relative errors of measurement for the 11 Growth Parameters; precision of Sp (spinal cord cone end positioning)

Reported performance (4 observations)

accuracyas written: “S-Fetus-Recognition accuracy”90.01
source quote (p.8)
“The accuracy of the S-Fetus-Recognition is 90.01%.”
accuracyas written: “S-fetus-Measure accuracy”85
source quote (p.8)
“The accuracy of the S-fetus-Measure is 85%.”
ppvas written: “Identification Precision of the 14 Standard Sections (non-inferiority)”stated without valueCI lower limit of the 95% CI for the difference of Identification Precision is greater than -10%
source quote (p.8)
“If the lower limit of the 95% CI for the difference of Identification Precision is greater than -10%, then the Identification Precision of the Standard Section of S-FetusAI function is considered non-inferior to manual recognition.”
ppvas written: “Sp (spinal cone end positioning) precision”stated without value
source quote (p.8)
“the Sp (spinal cone end positioning) precision was basically equal between the trial group and control group.”

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/K241949