6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)

K241671

Esaote S.p.A. · cleared 2025-05-16 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.4)
“The multifunctional ultrasound scanner is used to collect, display and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes. 6450 Ultrasound System is a general-purpose diagnostic ultrasound system, based on a mainframe platform that can be easily moved thanks to four swivelling wheels.”
AlgorithmXStrain LA is an advanced processing package for the Left Atrium analysis.
source quote (p.7)
“XStrain LA: XStrain allows clinicians to quantify endocardial velocities of contraction and relaxation and local deformation of the heart (Strain/Strain rate). XStrain LA is an advanced processing package for the Left Atrium analysis.”
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

sample size not stated · 3 site(s)

endpoints: LASr; LAScd; LASct

Reported performance (3 observations)

agreement_kappaas written: “ICC for LASr”0.84
source quote (p.8)
“The ICC, Intraclass Correlation Coefficient result is valid for all Left Atrium Strain indexes (LASr, LAScd and LASct): LASr = 0.84”
agreement_kappaas written: “ICC for LAScd”0.76
source quote (p.8)
“The ICC, Intraclass Correlation Coefficient result is valid for all Left Atrium Strain indexes (LASr, LAScd and LASct): LASr = 0.84 LAScd = 0,76”
agreement_kappaas written: “ICC for LASct”0.74
source quote (p.8)
“The ICC, Intraclass Correlation Coefficient result is valid for all Left Atrium Strain indexes (LASr, LAScd and LASct): LASr = 0.84 LAScd = 0,76 LASct = 0,74”

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/K241671