Premarket evidence — what FDA accepted

Device typehardware with ml

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. 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.”

AlgorithmAutoOB 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.

source quote (p.7)

“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

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=521 images

endpoints: The acceptance criteria are aimed to demonstrate the statistical equivalence between the automated and manual scan plane classification and between the automated and manual biometric measures results.; 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%; T-Test acceptance criteria: Automatic and manual measures are statistically equivalent (not rejecting the null hypothesis) with 95% confidence level.

standards: ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, Medical Electrical Equipment - Part 1: General Requirements for basic safety and essential performance, IEC 60601-1-2:2014+ AMD1:2020 (Ed. 4.1), Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, IEC 60601-1-6:2010+A1:2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability, IEC 60601-2-37:2007 +A1:2015, Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (Revision 3), NEMA UD 3-2004 (R2009), Standard For Real-Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment (Revision 2)

Retrospective clinical

n=100 images

endpoints: The acceptance criteria are aimed to demonstrate the statistical equivalence between the automated and manual biometric measures results.; IVS: Success Rate > 80%; LVID: Success Rate > 90%; LVPW: Success Rate > 70%; T-Test acceptance criteria: Automatic and manual measures are statistically equivalent (not rejecting the null hypothesis) with 95% confidence level.

standards: ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, Medical Electrical Equipment - Part 1: General Requirements for basic safety and essential performance, IEC 60601-1-2:2014+ AMD1:2020 (Ed. 4.1), Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, IEC 60601-1-6:2010+A1:2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability, IEC 60601-2-37:2007 +A1:2015, Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (Revision 3), NEMA UD 3-2004 (R2009), Standard For Real-Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment (Revision 2)

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). 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).