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. 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 AI software features SonoPelvicFloor and SonoLyst/ Sonolyst Live (workflow improvement) to the system.”

AlgorithmAI software features

source quote (p.6)

“The proposed Voluson Expert Series 22/20/18 adds additional AI software features SonoPelvicFloor and SonoLyst/ Sonolyst Live (workflow improvement) to the system.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (4)

Bench

sample size not stated

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 within cines; success rate of the suggested heart angle measurement

Reported performance (3 observations)

accuracyas written: “SonoLystIR sorting accuracy”stated without value

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”stated without value

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”stated without value

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

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 (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.

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).