LOGIQ E10s, LOGIQ Fortis

K231989

GE Medical Systems Ultrasound and Primary Care Diagnostic, · cleared 2023-11-07 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.5)

“The LOGIQ E10s and LOGIQ Fortis are general-purpose diagnostic ultrasound systems intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Addition of new software features: Auto Preset Assistant Auto Abdominal Color Assistant Auto Renal Measure Assistant App Launchpad Raw Data Streaming”

AlgorithmAI algorithms for Auto Renal Measure Assistant, Auto Abdominal Color Assistant, and Auto Preset Assistant

source quote (p.7)

“Auto Renal Measure Assistant : AI Summary of Testing Auto Abdominal Color Assistant: AI Summary of Testing Auto Preset Assistant : AI Summary of Testing”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedNo

Validation studies (3)

Retrospective clinical

n=30 patients · 2 site(s)

Retrospective clinical

n=50 patients

Retrospective clinical

n=110 patients

Reported performance (3 observations)

accuracyas written: “Longitudinal model length measurements average accuracy”96.45CI 95% CI of ± 1.26%

source quote (p.8)

“The Longitudinal model for length measurements has average accuracy of 96.45 with 95% CI of ± 1.26% and average absolute error of 0.35cm at 95% CI of ±0.12 cm.”

accuracyas written: “Transverse model width measurements average accuracy (first mention)”92.94CI 95% CI of ± 3.02%

source quote (p.8)

“The Transverse model for width measurements has average accuracy of 92.94% with 95% CI of ± 3.02% and average absolute error of 0.38cm at 95% CI of ±0.14 cm.”

accuracyas written: “Transverse model width measurements average accuracy (second mention)”93.13CI 95% CI of ± 3.63%

source quote (p.8)

“The Transverse model for width measurements has average accuracy of 93.13% with 95% CI of ± 3.63% and average absolute error of 0.37cm at 95% CI of ±0.14 cm.”

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

recalls in product code, 24mo

554

MAUDE reports in code, 12mo

+85%

vs code's own 3-yr baseline

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
re_clearance
The FDA AI/ML device list shows a newer 510(k) K253366 (decision 2026-01-07) from GE Medical Systems Ultrasound and Primary Care Diagnostics for a matching device line ("LOGIQ Fortis") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K253366
re_clearance
The FDA AI/ML device list shows a newer 510(k) K251963 (decision 2025-10-29) from Ge Medical Systems Ultrasound and Primary Care Diagnostics for a matching device line ("LOGIQ E10s") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251963
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).