ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System

K232145

Siemens Medical Solutions USA, Inc. · cleared 2023-10-30 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.8)

“The ACUSON Sequoia, Sequoia Select, and Origin will offer an optional cardiac imaging and analysis package with new transducers and software applications with Artificial Intelligent algorithms. The ACUSON Sequoia, Sequoia Select, and Origin will offer four (4) new software applications (Al Measure, Al Assist, 2D Heart^l, 4D Heart^l) containing Machine Learning that are specifically intended to support cardiac imaging for blood flow, valves and anatomical features and modifies the Indications for Use.”

AlgorithmArtificial Intelligent algorithms, Machine Learning

source quote (p.8)

“The ACUSON Sequoia, Sequoia Select, and Origin will offer an optional cardiac imaging and analysis package with new transducers and software applications with Artificial Intelligent algorithms. The ACUSON Sequoia, Sequoia Select, and Origin will offer four (4) new software applications (Al Measure, Al Assist, 2D Heart^l, 4D Heart^l) containing Machine Learning that are specifically intended to support cardiac imaging for blood flow, valves and anatomical features and modifies the Indications for Use.”

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedFDA source did not state this

Validation studies (5)

Bench

sample size not stated

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, UL 60601-1

Retrospective clinical

n=12 patients

endpoints: algorithm success rate (no adjustment or minor adjustment needed)

Retrospective clinical

n=45 cases · 5 site(s)

endpoints: Pearson correlation coefficient; Bland Altman bias

Retrospective clinical

n=32 patients · 5 site(s)

endpoints: Pearson correlation coefficient; Bland Altman bias

Retrospective clinical

n=32 patients · 5 site(s)

endpoints: algorithm success rate (acceptance of measurements as Pass or Pass with/Edit)

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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

recalls in product code, 24mo

554

MAUDE reports in code, 12mo

+85%

vs code's own 3-yr baseline

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
re_clearance
The FDA AI/ML device list shows a newer 510(k) K242523 (decision 2024-11-19) 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:K242523
re_clearance
The FDA AI/ML device list shows a newer 510(k) K240704 (decision 2024-07-22) 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:K240704
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
…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).