LOGIQ Fortis
K253366GE Medical Systems Ultrasound and Primary Care Diagnostics · cleared 2026-01-07 · product code IYN · Radiology
Premarket evidence — what FDA accepted
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.”
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.”
Validation studies (4)
Standalone
n=49 patients
endpoints: Detection accuracy; Sensitivity (True Positive Rate); Specificity (True Negative Rate); DICE Similarity Coefficient (Segmentation Accuracy)
standards: ISO 14971
Standalone
sample size not stated
endpoints: average keystrokes; Average accuracy; average absolute error; Limits of Agreement
standards: ISO 14971
Standalone
n=25 patients
endpoints: average reduction between keystrokes; Porta Hepatis measurement accuracy without segmentation scroll edit; Porta Hepatis measurement accuracy with segmentation scroll edit
standards: ISO 14971
Retrospective clinical
n=582 patients
endpoints: correlation coefficient; Bland-Altman analysis; offset; limit of agreement (LOA)
standards: ISO 14971
Reported performance (7 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.”
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).