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
source quote (p.5)
“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.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (3)

Standalone

n=60 images · 2 site(s)

endpoints: accuracy of measurement

Standalone

n=1,100 images · 2 site(s)

endpoints: overall model success rate

Standalone

n=2,600 images · 5 site(s)

endpoints: overall model success rate; accuracies of the algorithm against each class

Reported performance (3 observations)

accuracyas written: “Longitudinal model 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) average accuracy”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) average accuracy”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

85
recalls in product code, 24mo
554
MAUDE reports in code, 12mo
+85%
vs code's own 3-yr baseline
6
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

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/K231989