Sonosite LX and Sonosite PX Ultrasound Systems

K251106

Fujifilm Sonosite Inc · cleared 2025-08-29 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.12)
“The PIV Assist feature on Sonosite LX and Sonosite PX Ultrasound Systems is an enhanced implementation of previously cleared predicates Sonosite LX (K233597) and Sonosite PX (K213763).”
AlgorithmThe PIV Assist automates the localization of vein and artery in 2D Mode. When a candidate vein is centered, the PIV Assist can automatically detect both diameter and depth measurements, which are existing manual functionality that has been cleared on Sonosite LX (K233597) and Sonosite PX (K213763).
source quote (p.12)
“The PIV Assist automates the localization of vein and artery in 2D Mode. Both Sonosite LX (K233597) and Sonosite PX (K213763) provide functions that offer imaging assistance to the operator for vein sizing and depth when the vein is centered. The PIV Assist is an automation of the Catheter to Vein Ratio (CVR) feature cleared with Sonosite PX (K213763). When a candidate vein is centered, the PIV Assist can automatically detect both diameter and depth measurements, which are existing manual functionality that has been cleared on Sonosite LX (K233597) and Sonosite PX (K213763).”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

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, ANSI AAMI ISO 14971:2019

Reported performance (8 observations)

sensitivity0.9707CI 95% CI: 96%-98%
source quote (p.14)
“Vessel Recall is 97.07% (95% CI: 96%-98%)”
ppvas written: “Vessel Precision (L19-5 transducer)”0.9732CI 95% CI:97%- 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%)”
accuracyas written: “Vessel Classification for Veins Accuracy (L19-5 transducer)”0.9601CI 95% CI:95%-97%
source quote (p.14)
“Vessel Classification for Veins is 96.01% (95% CI:95%-97%)”
accuracyas written: “Vessel Classification for Arteries Accuracy (L19-5 transducer)”0.8971CI 95% CI: 87%-92%
source quote (p.14)
“Vessel Classification for Arteries is 89.71% (95% CI: 87%-92%).”
ppvas written: “Vessel Precision (L12-3 transducer)”0.9558CI 95% CI: 95%-96%
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%)”
sensitivityas written: “Vessel Recall (L12-3 transducer)”0.9449CI 95% CI: 93%-95%
source quote (p.14)
“Vessel Recall is 94.49% (95% CI: 93%-95%)”
accuracyas written: “Vessel Classification for Veins Accuracy (L12-3 transducer)”0.9454CI 95% CI: 93%-96%
source quote (p.14)
“Vessel Classification for Veins is 94.54% (95% CI: 93%-96%)”
accuracyas written: “Vessel Classification for Arteries Accuracy (L12-3 transducer)”0.8606CI 95% CI: 83%-89%
source quote (p.14)
“Vessel Classification for Arteries is 86.06% (95% CI: 83%-89%).”

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

85
recalls in product code, 24mo
554
MAUDE reports in code, 12mo
+85%
vs code's own 3-yr baseline
4
drift signals on this device
  • 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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K251106