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. (Page 3) ... Automated Radiological Image Processing Software 892.2050 (Page 4) ... 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). (Page 6)”
AlgorithmArtificial Intelligence based algorithms for LV endocardial border detection and tracking, breast lesion contouring, and 2D speckle tracking technology with AI-powered auto border detection for left ventricle.
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). (Page 6) ... eDetect for Breast Lesions contouring function supports the operator by detecting the lesion contour (with A.I. algorithm) in Breast measurements... (Page 6) ... 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). (Page 7)”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Retrospective clinical

n=100 images

endpoints: statistical equivalence between automated and manual assessment of the Breast Lesion contour and BIRADS parameters assessment; IOU Contour; Average Error; Shape Success Rate; Orientation Success Rate; Circumscribed Success Rate

Retrospective clinical

n=200 images

endpoints: Dice coefficient

Reported performance (11 observations)

iouas written: “Breast Lesion – IOU Contour Acceptance Threshold”0.85
source quote (p.9)
“Breast Lesion – IOU Contour Acceptance Threshold: 0.85”
diceas written: “mean Dice coefficient”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: “A2C End diastolic Dice coefficient”0.95CI ±0.02
source quote (p.11)
“A2C 0.95±0.02”
diceas written: “A2C End Systolic Dice coefficient”0.94CI ±0.03
source quote (p.11)
“A2C 0.94±0.03”
diceas written: “A2C Combined Dice coefficient”0.95CI ±0.02
source quote (p.11)
“A2C 0.95±0.02”
diceas written: “A4C End diastolic Dice coefficient”0.96CI ±0.02
source quote (p.11)
“A4C 0.96±0.02”
diceas written: “A4C End Systolic Dice coefficient”0.95CI ±0.02
source quote (p.11)
“A4C 0.95±0.02”
diceas written: “A4C Combined Dice coefficient”0.95CI ±0.02
source quote (p.11)
“A4C 0.95±0.02”
diceas written: “Combined End diastolic Dice coefficient”0.95CI ±0.02
source quote (p.11)
“Combined 0.95±0.02”
diceas written: “Combined End Systolic Dice coefficient”0.94CI ±0.02
source quote (p.11)
“Combined 0.94±0.02”
diceas written: “Combined Combined Dice coefficient”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); 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/K230179