Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
K231965GE Medical Systems Ultrasound and Primary Care Diagnostics, · cleared 2023-10-30 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.7)
“The proposed Voluson Expert Series 22/20/18 adds additional AI 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.”
source quote (p.7)
“The proposed Voluson Expert Series 22/20/18 adds additional AI 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.”
source quote (p.13)
“The Lower Limb view contains the grading criteria “Upper Leg visible”, “Lower leg visible”, "Foot visible". In order to simply the workflow for the user, these criteria are directly accessible to the user at view level as “Upper Leg”, “Lower Leg” and “Sagittal foot", without changing the algorithm.”
Validation studies (3)
Retrospective clinical
n=94 cases
endpoints: success rate should be 70% or higher; On datasets that were marked as challenging in image/cine quality measure the success rate of the feature should be 60% or higher
Retrospective clinical
n=78 cases
endpoints: The success rate of each AI component of the feature (uterus, endometrium, and fibroid segmentation) should be 70% or higher.
Retrospective clinical
n=2,570 other
endpoints: The average success rate of SonoLyst 2nd Trimester IR and X and overall traffic light accuracy is 80% or higher.
Reported performance (13 observations)
source quote (p.8)
“Our algorithm is shown to yield an accuracy of 96% on good IQ datasets and 93% on challenging IQ cases.”
source quote (p.8)
“Our algorithm is shown to yield an accuracy of 96% on good IQ datasets and 93% on challenging IQ cases.”
source quote (p.9)
“Good IQ: 96.2%”
source quote (p.9)
“Challenging IQ: 93.3%”
source quote (p.9)
“Rest: 100%”
source quote (p.9)
“Contraction: 93.75%”
source quote (p.9)
“Valsalva: 96.55%”
source quote (p.12)
“Uterus 0.89 ± 0.03”
source quote (p.12)
“Endometrium 0.70 ± 0.18”
source quote (p.12)
“Endometrium 0.29 ± 0.27”
source quote (p.12)
“Fibroids 0.70 ± 0.13”
source quote (p.12)
“Fibroids 0.48 ± 0.17”
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
- 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
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).