ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System

K242523

Siemens Medical Solutions USA, Inc. · cleared 2024-11-19 · product code IYN · Radiology

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. Also this Traditional 510(k) includes AI Abdomen which leverages AI Measure and AI Assist features released on the predicate ACUSON Origin (K240704), Trace AI which is an improvement of the generic eclipse measurement tool released on predicate ACUSON Origin (K240704) to enable an improved customer experience.”
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)
“AI 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.”
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 patients · 3 site(s)

endpoints: view classification success rate; Individual Equivalence Coefficient (IEC)

standards: ISO 10993-1, IEC 60601-1-6, ANSI AAMI ISO 14971, FDA Ultrasound Guidance document

Retrospective clinical

n=10 patients · 3 site(s)

endpoints: DICE coefficient

standards: ISO 10993-1, IEC 60601-1-6, ANSI AAMI ISO 14971, FDA Ultrasound Guidance document

Reported performance (2 observations)

accuracyas written: “view classification accuracy (excluding CBD and pancreas sagittal)”0.825
source quote (p.13)
“When eliminating CBD and pancreas sagittal from the aggregated results, the accuracy increased to 82.5%.”
diceas written: “DICE coefficient (lower 90% confidence bound)”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

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc.) — same firm and product code, not necessarily this device · 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 will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management

    recall event 95254 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc.) — same firm and product code, not necessarily this device · 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 will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management

    recall event 95254 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc.) — same firm and product code, not necessarily this device · 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 will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management

    recall event 95254 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc.) — same firm and product code, not necessarily this device · initiated 2024-02-23

    On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.

    recall event 94211 (openFDA)

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/K242523