Clarius OB AI

K233955

Clarius Mobile Health Corp. · cleared 2024-06-14 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typesimd
source quote (p.6)
“Clarius OB Al is a machine learning algorithm that is incorporated into the Clarius App software as part of the complete Clarius Ultrasound Scanner system for use in obstetric (OB) ultrasound imaging applications. Clarius OB Al is not a stand-alone software device.”
Algorithmmachine learning algorithm using a deep learning image segmentation algorithm, specifically a deep neural network (DNN) model
source quote (p.6)
“Clarius OB Al is a machine learning algorithm that is incorporated into the Clarius App software as part of the complete Clarius Ultrasound Scanner system for use in obstetric (OB) ultrasound imaging applications. ... using a deep learning image segmentation algorithm. The Clarius OB Al deep neural network (DNN) model was trained using three data sets: training, validation (tuning), and testing.”
Adaptive (vs locked)No
source quote (p.9)
“Ultrasound image processing software application implementing artificial intelligence utilizing non-adaptive machine learning algorithms trained with clinical and/or artificial data intended for”
PCCPYes
source quote (p.13)
“Modifications to Clarius OB Al will be made in accordance with its Predetermined Change Control Plan (PCCP). The PCCP provides a description of the device's planned modifications, a modification protocol to test, verify, validate, and implement the modifications in a manner that ensures the continued safety and effectiveness of the device, mitigating risks associated with changes to the OB Al model to not adversely impact the device's performance, safety, or effectiveness associated with its indications for use, and an impact assessment of the planned modifications.”
Cybersecurity addressedYes
source quote (p.11)
“Clarius conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed or transferred from a medical device to an external recipient.”

Validation studies (2)

Retrospective clinical

n=347 patients · 25 site(s)

endpoints: Verify that Clarius OB Al fetal biometric measurements (i.e., CRL, BPD, HC, AC, and FL) are non-inferior to manual measurements performed by expert clinicians.; Verify a high correlation between fetal gestational age calculated using manual expert measurements and Clarius OB Al biometric measurements.

standards: IEC 62304:2006 + A1:2015, ISO 14971:2019, NEMA PS 3.1 - 3.20 (2022d), IEC 62366-1:2015 + A1:2020, ISO 15223-1:2021

Prospective clinical

sample size not stated

endpoints: Evaluate the design and clinical utility of Clarius OB AI.; Determine if the device performs as intended in a representative user environment.; Determine if the device meets product requirements.; Determine if the device is clinically usable.; Determine if the device meets users' needs for use in semi-automated fetal biometric measurements.

standards: IEC 62304:2006 + A1:2015, ISO 14971:2019, NEMA PS 3.1 - 3.20 (2022d), IEC 62366-1:2015 + A1:2020, ISO 15223-1:2021

Reported performance (3 observations)

agreement_kappaas written: “Intraclass Correlation Coefficient (ICC)”0.99CI 0.994—0.997
source quote (p.13)
“ICC across all fetal biometrics between Clarius OB Al and the reviewers was calculated to be 0.99 (95% CI 0.994—0.997).”
iouas written: “Average Jaccard scores”stated without valueCI 0.72--0.74 to 0.93--0.94
source quote (p.13)
“The range of the average Jaccard scores (for all anatomical structures) between Clarius OB Al and the reviewers was 0.73 (95% CI 0.72--0.74) to 0.94 (95% CI 0.93--0.94)”
diceas written: “Average Dice scores”stated without valueCI 0.83--0.87 to 0.96--0.97
source quote (p.13)
“the range of the average dice scores (for all anatomical structures) between Clarius OB Al and the reviewers was 0.84 (95% CI 0.83--0.87) to 0.97 (95% CI 0.96--0.97).”

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
7
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K253593 (decision 2026-03-02) from Clarius Mobile Health Corp. for a matching device line ("Clarius Ejection Fraction AI") — a new clearance for the same line is a change event. The newer clearance's parsed summary mentions a PCCP.

    first seen 2026-07-08 · k_number:K253593

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K250226 (decision 2025-05-08) from Clarius Mobile Health Corp. for a matching device line ("Clarius Median Nerve AI") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K250226

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K243853 (decision 2025-04-16) from Clarius Mobile Health Corp. for a matching device line ("Clarius Prostate AI") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K243853

  • 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

  • …and 1 more.

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).

RIGOR™ Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: radar.healthai.com/precedent/device/K233955