6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
K241671Esaote S.p.A. · cleared 2025-05-16 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“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.”
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. Strain functionality Left atrium (LA) with manual segmentation.”
Validation studies (2)
Bench
sample size not stated
endpoints: acoustic output; biocompatibility; cleaning and disinfection effectiveness; thermal safety; electrical safety; electromagnetic safety; mechanical safety
standards: ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, IEC 60601-1-2:2014 + AMD1:2020 (Ed. 4.1), IEC 60601-1-6:2010+A1:2013, IEC 60601-2-37:2007 +A1:2015, NEMA UD 2-2004 (R2009), NEMA UD 3-2004 (R2009)
Retrospective clinical
sample size not stated · 2 site(s)
endpoints: Comparison of LASr, LAScd, and LASct results to TomTec reference; Intraclass Correlation Coefficient (ICC) for LASr, LAScd, and LASct
Reported performance (3 observations)
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”
source quote (p.8)
“The ICC, Intraclass Correlation Coefficient result is valid for all Left Atrium Strain indexes (LASr, LAScd and LASct): 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): 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
- 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).