Sonosite LX and Sonosite PX Ultrasound Systems
K251106Fujifilm Sonosite Inc · cleared 2025-08-29 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“The Sonosite LX and Sonosite PX ultrasound systems are general purpose ultrasound systems intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body.”
source quote (p.14)
“Summary of PIV Assist AI Algorithm Performance Testing:”
Validation studies (1)
Retrospective clinical
n=292 patients · 3 site(s)
endpoints: Vessel Precision; Vessel Recall; Vessel Classification for Veins; Vessel Classification for Arteries; Average Depth Error; Average Diameter Error
standards: ANSI AAMI IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes [Including Amendment 1 (2016), ANSI AAMI ISO 14971:2019 Medical devices - Application of risk management to medical devices
Reported performance (4 observations)
source quote (p.14)
“Vessel Recall is 97.07% (95% CI: 96%-98%)”
source quote (p.14)
“Vessel Precision for the L19-5 transducer when used on both Sonosite LX and Sonosite PX Ultrasound Systems is 97.32% (95% CI:97%- 98%)”
source quote (p.14)
“Vessel Recall is 94.49% (95% CI: 93%-95%)”
source quote (p.14)
“For the L12-3 transducer when used on both Sonosite LX and Sonosite PX Ultrasound Systems the results for Vessel Precision is 95.58% (95% CI: 95%-96%)”
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 (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, 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 is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97726
- 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).