Voluson Expert 22, Voluson Expert 20, Voluson Expert 18

K220358

GE Medical Systems Ultrasound and Primary Care Diagnostics, · cleared 2022-06-06 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (4)

Bench

sample size not stated

endpoints: acoustic output; biocompatibility; cleaning and disinfection effectiveness; thermal, electrical, electromagnetic, and mechanical safety

standards: AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, ISO14971, NEMA PS 3.1 - 3.20 (2022a)

Retrospective clinical

n=70 patients

endpoints: success rate of each AI component of the feature (MHD plane alignment, LH contour and measurements)

Retrospective clinical

n=5,000 cases

endpoints: sorting accuracy; grading accuracy

Retrospective clinical

n=250 patients

endpoints: success rate of the 4CH view and 3VT view suggestion; success rate of the suggested heart angle measurement

Reported performance (3 observations)

accuracyas written: “SonoLystIR sorting accuracy”80
source quote (p.9)
“For SonoLystIR the sorting accuracy is higher than 80% on a test data set containing 40000+ images.”
accuracyas written: “SonoLystX grading accuracy”80
source quote (p.9)
“For SonoLystX the grading accuracy is higher than 80% on a test data set containing 9500+ images.”
accuracyas written: “SonoLystLive accuracy”80
source quote (p.9)
“For SonoLystLive the accuracy is higher than 80% on a test data set containing 5500+ images.”

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
  • 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 matches this device's applicant.

    first seen 2026-07-08 · recall res_event_number:97726

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K252328 (decision 2025-11-24) from Ge Medical Systems Ultrasound and Primary Care Diagnostics for a matching device line ("Voluson Expert 18; Voluson Expert 20; Voluson Expert 22") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K252328

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K242168 (decision 2024-12-20) from GE Medical Systems Ultrasound and Primary care Diagnostics for a matching device line ("Voluson Expert 18; Voluson Expert 20; Voluson Expert 22") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K242168

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K231965 (decision 2023-10-30) from GE Medical Systems Ultrasound and Primary Care Diagnostics, for a matching device line ("Voluson Expert 22, Voluson Expert 20, Voluson Expert 18") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K231965

  • 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 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.

Recalls attributed to this device

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 clinical decisions impacting overall care.

    recall event 97726 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 clinical decisions impacting overall care.

    recall event 97726 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 clinical decisions impacting overall care.

    recall event 97726 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · initiated 2025-03-06

    The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

    recall event 96538 (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/K220358