LOGIQ Totus
K253370GE Medical Systems Ultrasound and Primary Care Diagnostics · cleared 2026-01-08 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The LOGIQ Totus is full featured, Track 3 device, primarily intended for general purpose diagnostic ultrasound system which consists of a mobile console approximately 490mm wide (monitor width: 545mm), 835mm deep and 1415~1815mm high that provides digital acquisition, processing and display capability.”
source quote (p.7)
“During the migration of the AI software feature from LOGIQ E10s (K231989), the algorithm was not retrained and there were no changes to the algorithmic flow or the AI components performing the inferencing.”
source quote (p.7)
“During the migration of the AI software feature from LOGIQ E10s (K231989), the algorithm was not retrained and there were no changes to the algorithmic flow or the AI components performing the inferencing.”
Validation studies (4)
Retrospective clinical
n=582 patients
endpoints: least squares fit (estimation) between the acoustic property measurements and the corresponding MRI Proton Density Fat Fraction (MRI-PDFF %) measurements; correlation between UFF values and MRI-PDFF; Bland-Altman analysis between UGFF and MRI-PDFF
Retrospective clinical
n=20 patients
endpoints: correlation between UFF values and MRI-PDFF; Bland-Altman analysis between UGFF and MRI-PDFF
Retrospective clinical
n=24 patients
endpoints: correlation between UGFF and UDFF; Bland-Altman analysis between UGFF and UDFF
Bench
sample size not stated
endpoints: acoustic output; biocompatibility; cleaning and disinfection effectiveness; thermal, electrical, electromagnetic and mechanical safety
standards: ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION, IEC 60601-2-37 Edition 3.0 2024, IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION, ISO 10993-1 Fifth edition 2018-08, ISO 14971 Third Edition 2019-12, NEMA PS 3.1 - 3.20 2024e, AAMI TIR69:2017/(R2020)
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
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).