Voluson Expert 22, Voluson Expert 20, Voluson Expert 18

K231965

GE Medical Systems Ultrasound and Primary Care Diagnostics, · cleared 2023-10-30 · 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. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate real-time three-dimensional imaging supporting all standard acquisition modes. The proposed Voluson Expert Series 22/20/18 adds additional Al software features SonoPelvicFloor2.0 (extension of existing Feature SonoPelvicFloor), SonoAVC2.0 (extension of existing Feature SonoAVC), Fibroid Mapping (as part of Option SonoGYN) to the system. Additional the existing features SonoLyst/ Sonolyst Live have been improved.”
AlgorithmAI software features for SonoPelvicFloor2.0, SonoAVC2.0, Fibroid Mapping, and improvements to SonoLyst/SonoLyst Live.
source quote (p.7)
“The proposed Voluson Expert Series 22/20/18 adds additional Al software features SonoPelvicFloor2.0 (extension of existing Feature SonoPelvicFloor), SonoAVC2.0 (extension of existing Feature SonoAVC), Fibroid Mapping (as part of Option SonoGYN) to the system. Additional the existing features SonoLyst/ Sonolyst Live have been improved.”
Adaptive (vs locked)No
source quote (p.13)
“The sagittal spine view contained the grading criteria “Sacrum visible”, “Lumbar visible”, “Thoracic visible”, and “Cervical visible”. In order to simply the workflow for the user, these criteria are directly accessible to the user at view level as “Spine Sacrum”, “Spine Lumber” “Spine Thoracic”, and “Spine Cervical”, without changing the underlaying AI algorithm.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (3)

Retrospective clinical

n=94 cases

endpoints: success rate; accuracy

Retrospective clinical

n=78 cases

endpoints: success rate; DICE scores

Retrospective clinical

n=2,570 cases

endpoints: average agreement; success rate; traffic light accuracy; sorting accuracy; grading accuracy

Reported performance (13 observations)

accuracyas written: “accuracy on good IQ datasets (SonoPelvicFloor2.0)”0.96
source quote (p.8)
“Our algorithm is shown to yield an accuracy of 96% on good IQ datasets and 93% on challenging IQ cases.”
accuracyas written: “accuracy on challenging IQ cases (SonoPelvicFloor2.0)”0.93
source quote (p.8)
“Our algorithm is shown to yield an accuracy of 96% on good IQ datasets and 93% on challenging IQ cases.”
accuracyas written: “accuracy on Good IQ subgroup (SonoPelvicFloor2.0)”0.962
source quote (p.9)
“Good IQ: 96.2%”
accuracyas written: “accuracy on Challenging IQ subgroup (SonoPelvicFloor2.0)”0.933
source quote (p.9)
“Challenging IQ: 93.3%”
accuracyas written: “accuracy on Rest subgroup (SonoPelvicFloor2.0)”1
source quote (p.9)
“Rest : 100%”
accuracyas written: “accuracy on Contraction subgroup (SonoPelvicFloor2.0)”0.9375
source quote (p.9)
“Contraction: 93.75%”
accuracyas written: “accuracy on Valsalva subgroup (SonoPelvicFloor2.0)”0.9655
source quote (p.9)
“Valsalva: 96.55%”
diceas written: “DICE score Uterus successful (Fibroid Mapping)”0.89CI ± 0.03
source quote (p.12)
“Uterus 0.89 ± 0.03”
diceas written: “DICE score Endometrium successful (Fibroid Mapping)”0.7CI ± 0.18
source quote (p.12)
“Endometrium 0.70 ± 0.18”
diceas written: “DICE score Fibroids successful (Fibroid Mapping)”0.7CI ± 0.13
source quote (p.12)
“Fibroids 0.70 ± 0.13”
diceas written: “DICE score Endometrium failed (Fibroid Mapping)”0.29CI ± 0.27
source quote (p.12)
“Endometrium 0.29 ± 0.27”
diceas written: “DICE score Fibroids failed (Fibroid Mapping)”0.48CI ± 0.17
source quote (p.12)
“Fibroids 0.48 ± 0.17”
accuracyas written: “average success rate and overall traffic light accuracy (SonoLyst/SonoLyst Live)”0.8
source quote (p.13)
“The average success rate of SonoLyst 2nd Trimester IR and X and overall traffic light accuracy is 80% or higher.”

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
6
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

  • 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

  • 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 is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95254

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/K231965