Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
K242168GE Medical Systems Ultrasound and Primary care Diagnostics · cleared 2024-12-20 · product code IYN · Radiology
Premarket evidence — what FDA accepted
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 18/20/22 adds additional AI software features SonoLyst 1st Trimester and Sono Pelvic floor 3.0: which includes MHD (valsava manoeuver detection) and Anal sphincter”
source quote (p.7)
“The proposed Voluson Expert Series 18/20/22 adds additional AI software features SonoLyst 1st Trimester and Sono Pelvic floor 3.0: which includes MHD (valsava manoeuver detection) and Anal sphincter The proposed Voluson Expert Series 18/20/22 updated existing AI software features SonoLyst 2nd Trimester and SonoAVC follicle 2.0”
source quote (p.19)
“AAMI TIR69:2017/(R2020), Risk management of radio-frequency wireless coexistence for medical devices and systems”
Validation studies (5)
Retrospective clinical
n=93 cases
endpoints: success rate
Retrospective clinical
n=106 cases
endpoints: success rate
Retrospective clinical
n=138 cases
endpoints: success rate; Accuracy; Dice Coefficient
Retrospective clinical
n=2,200,000 images
endpoints: average agreement; average success rate
Retrospective clinical
n=35,861 patients
endpoints: average agreement; acceptability rate; average success rate
Reported performance (9 observations)
source quote (p.12)
“On test data acquired together with train cohort: 94.73%”
source quote (p.12)
“On test data, acquired consecutively post model development: 92.8%”
source quote (p.12)
“Overall Accuracy: 93.6%”
source quote (p.13)
“3-5 0.937619”
source quote (p.13)
“5-10 0.946289”
source quote (p.13)
“10-15 0.962315”
source quote (p.13)
“>15 0.93206”
source quote (p.15)
“The average success rate of SonoLyst 2nd Trimester IR and X and overall traffic light accuracy is 80% or higher”
source quote (p.17)
“The average success rate of SonoLyst 1st Trimester IR, X and SonoBiometry CRL 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
- 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).