LOGIQ Fortis

K253366

GE Medical Systems Ultrasound and Primary Care Diagnostics · cleared 2026-01-07 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“The LOGIQ Fortis is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 575 mm wide (keyboard), 925 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a digital keyboard (physical keyboard as an option), specialized controls, 12-inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor (or 23.8-inch High Resolution LED LCD monitor as an option).”
AlgorithmModel detection accuracy and DICE score for anatomical segmentation
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”
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

endpoints: detection accuracy (sensitivity and specificity); DICE score

Standalone

n=36 patients

endpoints: average keystrokes to obtain the Anteroposterior (AP) measurement; Average accuracy; average absolute error; Limits of Agreement

Standalone

n=25 patients

endpoints: average reduction between keystrokes; Porta Hepatis measurement accuracy; Average accuracy; average absolute error; Limits of Agreement

Retrospective clinical

n=582 patients

endpoints: correlation between UFF values and MRI-PDFF; offset; limit of agreement (LOA)

Retrospective clinical

n=20 patients

endpoints: correlation between UFF values and MRI-PDFF; offset; limit of agreement (LOA)

Retrospective clinical

n=24 patients

endpoints: correlation between UGFF and UDFF; offset; limit of agreement (LOA)

Reported performance (8 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.”
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: “Average accuracy (Long View AP Measurement)”87.2CI +/- 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: “Average accuracy (Short View AP Measurement)”92.9CI +/- 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: “Average accuracy (Short View Trans Measurement)”86.9CI +/- 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: “Average accuracy (Porta Hepatis measurement accuracy without segmentation scroll edit)”59.85CI +/- 17.86%
source quote (p.11)
“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: “Average accuracy (Porta Hepatis measurement accuracy with segmentation scroll edit)”80.56CI +/- 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/K253366