LOGIQ E10

K251985

Ge Medical Systems Ultrasound and Primary Care Diagnostics · cleared 2025-10-29 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
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”
AlgorithmAI-powered detection, measurement, and segmentation algorithms for anatomical structures (Aorta, Kidney, Liver/Spleen/IVC, Gallbladder/Urinary Bladder, Pancreas, Air view, Common Bile Duct) and a least squares fit estimation for Ultrasound Guided Fat Fraction (UGFF) index.
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 The UGFF index is based on a least squares fit (estimation) between the acoustic property measurements and the corresponding MRI Proton Density Fat Fraction (MRI-PDFF %) measurements.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (6)

Standalone

n=49 patients · 1 site(s)

endpoints: Detection accuracy; Sensitivity (True Positive Rate); Specificity (True Negative Rate); DICE Similarity Coefficient (Segmentation Accuracy)

Standalone

sample size not stated · 2 site(s)

endpoints: Average keystrokes; Average accuracy; Average absolute error; Limits of Agreement

Standalone

sample size not stated · 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

sample size not stated · 2 site(s)

endpoints: Correlation coefficient; Offset; Limit of agreement; Differences between UFF and MRI-PDFF values

Retrospective clinical

n=24 patients · 1 site(s)

endpoints: Correlation coefficient; Offset; Limit of agreement; Differences between UFF and UDFF values

Reported performance (9 observations)

sensitivity0.91
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.”
specificity0.98
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.”
accuracyas written: “Detection accuracy”0.948
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.”
diceas written: “DICE Similarity Coefficient (Segmentation Accuracy)”0.82
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.”
accuracyas written: “Long View AP Measurement Accuracy”0.872CI +/- 1.98%
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.”
accuracyas written: “Short View AP Measurement Accuracy”0.929CI +/- 2.02%
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.”
accuracyas written: “Short View Trans Measurement Accuracy”0.869CI +/- 6.25%
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.”
accuracyas written: “Porta Hepatis measurement accuracy without segmentation scroll edit”0.5985CI +/- 17.86%
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.”
accuracyas written: “Porta Hepatis measurement accuracy with segmentation scroll edit”0.8056CI +/- 8.83%
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

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 (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

Recalls attributed to this device

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 clinical decisions impacting overall care.

    recall event 97726 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 clinical decisions impacting overall care.

    recall event 97726 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 clinical decisions impacting overall care.

    recall event 97726 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · initiated 2025-03-06

    The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

    recall event 96538 (openFDA)

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/K251985