LOGIQ E10
K251985Ge 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 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. 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. Addition of new software features: Auto Abdominal Color Assistant 2.0 for adult imaging (Auto Abdominal Color Assistant 1.0 cleared on K231966) Auto Abdominal Measure Assistant (AI) consists of: Auto Renal Measure Assistant (Cleared on LOGIQ E10 K231966) Auto Aorta Measure Assistant Auto Common Bile Duct (CBD) Measure Assistant”
source quote (p.9)
“The overall model detection accuracy (sensitivity and specificity) and DICE score for the Aorta, Kidney, Liver/Spleen/inferior vena cava (IVC), Gallbladder (GB)/Urinary Bladder, Pancreas, and Air view is expected to be as follows: Detection accuracy ≥ 80% (0.80) Sensitivity (True Positive Rate): ≥ 80% (0.80) Specificity (True Negative Rate): ≥ 80% (0.80) DICE Similarity Coefficient (Segmentation Accuracy): ≥ 0.80”
Validation studies (6)
Retrospective clinical
n=49 patients
endpoints: Detection accuracy; Sensitivity; Specificity; DICE Similarity Coefficient
Retrospective clinical
n=36 patients · 2 site(s)
endpoints: Average keystrokes; Average accuracy; Average absolute error; Limits of Agreement
Retrospective clinical
n=25 patients · 2 site(s)
endpoints: Average reduction between keystrokes; Average accuracy; Average absolute error; Limits of Agreement
Retrospective clinical
n=582 patients · 1 site(s)
endpoints: Correlation coefficient; Offset; Limit of Agreement; Differences between UFF and MRI-PDFF values
Retrospective clinical
n=15 patients
endpoints: Correlation coefficient; Offset; Limit of Agreement; Differences between UFF and MRI-PDFF values
Retrospective clinical
n=24 patients
endpoints: Correlation coefficient; Offset; Limit of Agreement; Differences between UFF and MRI-PDFF values
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).