Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.8)

“The ACUSON Sequoia, Sequoia Select, Origin and Origin ICE Diagnostic Ultrasound Systems are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. The ultrasound system function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes, Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging (except Origin), Virtual Touch – pSWE Imaging, Virtual Touch – SWE Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging or Harmonic Imaging on a Display and provide cardiac anatomical and quantitative function software applications.”

AlgorithmAI Abdomen covers a set of semi-automated Abdomen view classifications and measurements for B-Mode acquisitions. Trace AI is a semi-automated measurement tool that provides an ability to measure orifice-type anatomic structures on MPRs generated from volumetric ICE, TEE and TTE transducers.

source quote (p.13)

“Al Abdomen covers a set of semi-automated Abdomen view classifications and measurements for B-Mode acquisitions. Trace Al is a semi-automated measurement tool that provides an ability to measure orifice-type anatomic structures on MPRs generated from volumetric ICE, TEE and TTE transducers.”

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)

Retrospective clinical

n=105 cases · 3 site(s)

endpoints: view classification success rate; Individual Equivalence Coefficient (IEC) for semi-automated measurements

standards: IEC 62359: Edition 2.1 2017-09, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields / Combines IEC 62359 (2010-10) and AMD 1 (2017-09), AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005), IEC 60601-1:2005/A1(2012), Medical electric equipment – Part 1: General requirements for basic safety and essential performance / This document and its separate amendments continue to be valid together with the consolidated version, IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, IEC 60601-2-18: Edition 3.0 2009-08, Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment, IEC 60601-2-37 Edition 2.1 2015, Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, ISO 10993-1 Fifth edition 2018-08, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, IEC 60601-1-6:2010+A1:2013+A2:2020 Medical Electrical Equipment Part 1-6, General Requirements for Basic Safety and Essential Performance- Collateral standard: Usability, ANSI AAMI ISO 14971: Medical devices- Applications of risk management to medical devices, 2019, FDA Ultrasound Guidance document, “Marketing Clearance of Diagnostic Ultrasound Systems and Transducers,” issued in February 2023 (https://www.fda.gov/media/71100/download) for determining the measurement accuracy

Retrospective clinical

n=10 patients · 3 site(s)

endpoints: DICE coefficient for orifice-type anatomic structures measurement

standards: IEC 62359: Edition 2.1 2017-09, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields / Combines IEC 62359 (2010-10) and AMD 1 (2017-09), AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005), IEC 60601-1:2005/A1(2012), Medical electric equipment – Part 1: General requirements for basic safety and essential performance / This document and its separate amendments continue to be valid together with the consolidated version, IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, IEC 60601-2-18: Edition 3.0 2009-08, Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment, IEC 60601-2-37 Edition 2.1 2015, Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, ISO 10993-1 Fifth edition 2018-08, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, IEC 60601-1-6:2010+A1:2013+A2:2020 Medical Electrical Equipment Part 1-6, General Requirements for Basic Safety and Essential Performance- Collateral standard: Usability, ANSI AAMI ISO 14971: Medical devices- Applications of risk management to medical devices, 2019, FDA Ultrasound Guidance document, “Marketing Clearance of Diagnostic Ultrasound Systems and Transducers,” issued in February 2023 (https://www.fda.gov/media/71100/download) for determining the measurement accuracy

Reported performance (1 observation)

diceas written: “Trace AI DICE coefficient (lower 90% confidence bound for the 90th percentile)”0.95CI 90% confidence

source quote (p.15)

“The lower 90% confidence bound for the 90th percentile is 0.95, which is greater than the requirement of 0.8, therefore, the test passes.”

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

5

drift signals on this device

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 matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:95254
re_clearance
The FDA AI/ML device list shows a newer 510(k) K251481 (decision 2025-08-20) from Siemens Medical Solutions USA, Inc. for a matching device line ("ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251481
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 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).