6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)

K243253

Esaote S.p.A. · cleared 2025-06-18 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.5)
“6600 Ultrasound System is a general-purpose diagnostic ultrasound system, based on a mainframe platform that can be easily moved thanks to four swivelling wheels.”
AlgorithmA.I. algorithms for classification, segmentation, and measurement for Automatic Obstetric Biometric Measurement (AutoOB) and Automatic Cardiac Measurement (AutoCM).
source quote (p.6)
“1. AutoOB: AutoOB (Automatic Obstetric Biometric Measurement) is a tool based on A.I. algorithms that supports the clinician in performing the Obstetric Biometric Measurements during an Obstetric ultrasound examination. 2. AutoCM: AutoCM (Automatic Cardiac Measurement), is a tool based on A.I. algorithm that supports the clinician in performing the Cardiac Measurements during a Cardiac ultrasound examination. AutoOB tool is based on two different A.I. algorithms: An algorithm for the classification of the acquired scan plane An algorithm for the segmentation and measurement AutoCM tool is based on an algorithm for the segmentation and measurement.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Retrospective clinical

n=521 images

endpoints: Head TT/TV plane: success rate > 90%; Head TCD plane: success rate > 90%; Abdomen plane: success rate > 90%; Bones: success rate > 90%; Sagittal CRL: success rate >90%; Sagittal NT: success rate > 85%; Head Circumference (HC): Success Rate >= 90%; Biparietal Diameter (BPD): Success Rate >= 90%; Abdominal Circumference (AC): Success Rate >= 90%; Femur Length (FL): Success Rate>=75%; Crown Rump Length (CRL): Success Rate>=75%; Transverse cerebellar diameter (TCD): Success Rate >= 90%; Humerus Length (HL): Success Rate>=90%; Ulna Length (UL): Success Rate>=90%; Tibia Length (TL): Success Rate>= 90%; Automatic and manual measures are statistically equivalent (not rejecting the null hypothesis) with 95% confidence level.

Retrospective clinical

n=100 images

endpoints: IVS: Success Rate > 80%; LVID: Success Rate > 90%; LVPW: Success Rate > 70%; Automatic and manual measures are statistically equivalent (not rejecting the null hypothesis) with 95% confidence level.

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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/K243253