LOGIQ E10
K231966GE Medical Systems Ultrasound and Primary care Diagnostics, · cleared 2023-11-07 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“The LOGIQ E10 is a full featured, track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 991 mm deep and 1300 mm high that provides digital acquisition, processing and display capability.”
source quote (p.7)
“Auto Renal Measure Assistant: AI Summary of Testing”
Validation studies (3)
Retrospective clinical
n=30 patients · 2 site(s)
endpoints: accuracy of measurement; average absolute error
Retrospective clinical
n=50 patients
endpoints: overall model success rate; accuracies of the algorithm against each class
Retrospective clinical
n=110 patients
endpoints: overall model success rate; accuracies of the algorithm against each class
Reported performance (3 observations)
source quote (p.7)
“The Longitudinal model for length measurements has average accuracy of 96.45 with 95% CI of ± 1.26%”
source quote (p.7)
“The Transverse model for width measurements has average accuracy of 92.94% with 95% CI of ± 3.02%”
source quote (p.7)
“The Transverse model for width measurements has average accuracy of 93.13% with 95% CI of ± 3.63%”
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 (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 matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:97726
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K251985 (decision 2025-10-29) from Ge Medical Systems Ultrasound and Primary Care Diagnostics for a matching device line ("LOGIQ E10") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251985
- 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 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).