LOGIQ E10s
K251963Ge Medical Systems Ultrasound and Primary Care Diagnostics · cleared 2025-10-29 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The LOGIQ E10s 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. The user interface includes a computer keyboard, specialized controls, 12-inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor. automated radiological image processing software, 21 CFR 892.2050, 90-QIH”
Validation studies (6)
Retrospective clinical
n=49 patients
endpoints: Detection accuracy; Sensitivity (True Positive Rate); Specificity (True Negative Rate); DICE Similarity Coefficient (Segmentation Accuracy)
Retrospective clinical
sample size not stated
endpoints: Average accuracy; average absolute error; Limits of Agreement
Retrospective clinical
sample size not stated
endpoints: Average accuracy; average absolute error; Limits of Agreement
Retrospective clinical
n=582 patients · 1 site(s)
endpoints: correlation coefficient; offset; limit of agreement (LOA); differences between UFF and MRI-PDFF values were within; results in patients were smaller than the LOA
Retrospective clinical
n=20 patients · 2 site(s)
endpoints: correlation coefficient; offset; limit of agreement (LOA); differences between UFF and MRI-PDFF values were within; results in patients were smaller than the LOA
Retrospective clinical
n=24 patients · 1 site(s)
endpoints: correlation coefficient; offset; limit of agreement (LOA); differences between UFF and MRI-PDFF values were within; results in all patients were smaller than the LOA
Reported performance (9 observations)
source quote (p.9)
“The model achieved accuracy of 94.8%, with sensitivity of 0.91, specificity of 0.98, and a DICE score of 0.82, all of which meet the predefined acceptance criteria.”
source quote (p.9)
“The model achieved accuracy of 94.8%, with sensitivity of 0.91, specificity of 0.98, and a DICE score of 0.82, all of which meet the predefined acceptance criteria.”
source quote (p.9)
“The model achieved accuracy of 94.8%, with sensitivity of 0.91, specificity of 0.98, and a DICE score of 0.82, all of which meet the predefined acceptance criteria.”
source quote (p.9)
“The model achieved accuracy of 94.8%, with sensitivity of 0.91, specificity of 0.98, and a DICE score of 0.82, all of which meet the predefined acceptance criteria.”
source quote (p.10)
“Average accuracy is 87.2% with 95% CI of +/- 1.98% and average absolute error of 0.253 cm and 95% CI of 0.049 cm.”
source quote (p.10)
“Average accuracy is 92.9% with a 95% CI of +/- 2.02% and an average absolute error of 0.128 cm and 95% CI of 0.037 cm.”
source quote (p.10)
“Average accuracy is 86.9% with 95% CI of +/- 6.25% and average absolute error of 0.235 cm and 95% CI of 0.110 cm.”
source quote (p.12)
“Average accuracy is 59.85% with 95% CI of +/- 17.86% and average absolute error of 1.66 mm and 95% CI of 1.02 mm.”
source quote (p.12)
“Average accuracy is 80.56% with a 95% CI of +/- 8.83% and an average absolute error 0.91 mm and 95% CI of 0.45 mm.”
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
- 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).