Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
K252328Ge Medical Systems Ultrasound and Primary Care Diagnostics · cleared 2025-11-24 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“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.”
source quote (p.6)
“The existing cleared Probe C1-6-D is being added to previously cleared SW- AI Feature Sonolyst 1st Trimester.”
Validation studies (1)
Standalone
n=396 patients
endpoints: sorting (SonoLyst IR) and grading (SonoLyst X) features; average agreement between a sonographer panel and the output of the algorithm regarding Traffic light quality (green/amber/none); acceptability rate for the placement of CRL callipers; average success rate of SonoLyst 1st Trimester IR, X and SonoBiometry CRL and overall traffic light accuracy
standards: IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION, IEC60601-1-2, IEC60601-2-37, ISO10993-1, ISO14971, NEMA PS 3.1 - 3.20 (2023e), AAMI TIR69:2017/(R2020), IEC62359 Edition 2.1 2017-09 Consolidated Version
Reported performance (3 observations)
source quote (p.8)
“SonoLystIR 0.93 0.80”
source quote (p.8)
“SonoLystX 0.84 0.80”
source quote (p.8)
“SonoLystLive 0.84 0.70”
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
- 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).