6440 MyLabX90

K230179

Esaote S.p.A. · cleared 2023-11-29 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.3)
“The multifunctional ultrasound scanner MyLabX90 is used to collect, display, and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes. Automated Radiological Image Processing Software 892.2050. The AutoEF, based on Artificial Intelligence, detects and track, automatically, the LV endocardial border to calculate LV Volumes (Diastolic Volume - Systolic Volume) and EF (Ejection Fraction).”
AlgorithmArtificial Intelligence (A.I.) algorithm for LV endocardial border detection and breast lesion contouring; 2D speckle tracking technology with A.I. for XStrain.
source quote (p.6)
“The AutoEF, based on Artificial Intelligence, detects and track, automatically, the LV endocardial border to calculate LV Volumes (Diastolic Volume - Systolic Volume) and EF (Ejection Fraction). The software module (powered with A.I.) is registered by Pie Medical Imaging B.V. as Caas Qardia (K212376). eDetect for Breast Lesions contouring function supports the operator by detecting the lesion contour (with A.I. algorithm) in Breast measurements. XStrain allows clinicians to quantify endocardial velocities of contraction and relaxation and local deformation of the heart (Strain/Strain rate). Based on 2D speckle tracking technology with Angle-independent technology. A.I. Powered for auto border detection of left ventricle (LV).”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=20 patients

endpoints: statistical equivalence between automated and manual assessment of the Breast Lesion contour and BIRADS parameters assessment; IOU Contour Acceptance Threshold: 0.85; Average Error < 0.15; Shape Success Rate > 80%; Orientation Success Rate > 90%; Circumscribed Success Rate > 75%

Retrospective clinical

n=399 patients

endpoints: Dice coefficient

Reported performance (11 observations)

iouas written: “IOU Contour Acceptance Threshold”stated without value
source quote (p.9)
“IOU Contour Acceptance Threshold: 0.85”
diceas written: “Average Dice coefficient (A2C/A4C algorithm)”0.95CI 0.02
source quote (p.11)
“For the A2C/A4C algorithm, the average Dice coefficient is 0.95 with a standard deviation of 0.02 for the 200 individually segmented frames.”
diceas written: “Dice coefficient (A2C End diastolic)”0.95CI 0.02
source quote (p.11)
“A2C 0.95±0.02”
diceas written: “Dice coefficient (A2C End Systolic)”0.94CI 0.03
source quote (p.11)
“A2C 0.94±0.03”
diceas written: “Dice coefficient (A2C Combined)”0.95CI 0.02
source quote (p.11)
“A2C 0.95±0.02”
diceas written: “Dice coefficient (A4C End diastolic)”0.96CI 0.02
source quote (p.11)
“A4C 0.96±0.02”
diceas written: “Dice coefficient (A4C End Systolic)”0.95CI 0.02
source quote (p.11)
“A4C 0.95±0.02”
diceas written: “Dice coefficient (A4C Combined)”0.95CI 0.02
source quote (p.11)
“A4C 0.95±0.02”
diceas written: “Dice coefficient (Combined End diastolic)”0.95CI 0.02
source quote (p.11)
“Combined 0.95±0.02”
diceas written: “Dice coefficient (Combined End Systolic)”0.94CI 0.02
source quote (p.11)
“Combined 0.94±0.02”
diceas written: “Dice coefficient (Combined Combined)”0.95CI 0.02
source quote (p.11)
“Combined 0.95±0.02”

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). 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).

RIGOR™ Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: radar.healthai.com/precedent/device/K230179