Radiology AI Directory

FDA-cleared profile

LOGIQ E10

Ge Medical Systems Ultrasound and Primary Care Diagnostics

Authorized purpose: LOGIQ E10 is a general diagnostic ultrasound system for qualified users across fetal and obstetric, abdominal, gynecologic, pediatric, small-organ, breast, cardiac, vascular, musculoskeletal, urologic, transrectal, transvaginal, transesophageal, and intraoperative applications.

Breast imagingCardiac imagingUltrasound workflow
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Product overview

Start with the essentials

Authorized purpose: LOGIQ E10 is a general diagnostic ultrasound system for qualified users across fetal and obstetric, abdominal, gynecologic, pediatric, small-organ, breast, cardiac, vascular, musculoskeletal, urologic, transrectal, transvaginal, transesophageal, and intraoperative applications.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: LOGIQ E10 is a general diagnostic ultrasound system for qualified users across fetal and obstetric, abdominal, gynecologic, pediatric, small-organ, breast, cardiac, vascular, musculoskeletal, urologic, transrectal, transvaginal, transesophageal, and intraoperative applications.

Evidence takeaway

Evidence from the reviewed source record: K251985 reports AI model testing on 49 subjects and 1,186 annotated images with overall accuracy 94.8%, sensitivity 0.91, specificity 0.98, and Dice 0.82. A Japanese UGFF study included 582 subjects and reported correlation 0.87 with MRI-PDFF; confirmatory US/EU testing included 15 subjects and reported correlation 0.90. These results apply to the named functions and tested populations, not every LOGIQ E10 examination.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
LOGIQ E10 is a general diagnostic ultrasound system for qualified users across fetal and obstetric, abdominal, gynecologic, pediatric, small-organ, breast, cardiac, vascular, musculoskeletal, urologic, transrectal, transvaginal, transesophageal, and intraoperative applications.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Added in P2 round17 from the exact FDA decision material; later product-family claims remain separate.

Intended users
Qualified physicians, sonographers, and other trained ultrasound professionals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Care setting and population
Hospitals, clinics, offices, operating rooms, and point-of-care environments within the cleared applications.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
Ultrasound acquisition, measurement, analysis, reporting, and release-specific AI assistance.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
Live or imported ultrasound data from supported probes, systems, host devices, and applications.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Output and human action
Ultrasound images, measurements, calculations, overlays, and reports for clinician review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Limitations
AI-assisted measurements, views, and guidance do not replace image-quality assessment or clinician interpretation; supported probes, host devices, populations, and features differ by release.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K251985
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Anatomy
Multi-region
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-10-29
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Validate supported probes and host devices, patient matching, DICOM or local export, PACS measurements, worklist, report transfer, and offline or downtime behavior.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K251985; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Deployment and data flow
Ultrasound hardware or software with supported probes, host devices, licensed options, and network configuration.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K251985; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-03

Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Only qualified physicians, sonographers, and other trained ultrasound professionals should operate or interpret the product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Monitoring and change control
Monitor by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: AI-assisted measurements, views, and guidance do not replace image-quality assessment or clinician interpretation; supported probes, host devices, populations, and features differ by release.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K251985; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled AI functions to K251985 before acceptance.

exact submission · checked 2026-09-03

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

Validate supported probes and host devices, patient matching, DICOM or local export, PACS measurements, worklist, report transfer, and offline or downtime behavior.

product family · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. Vendor statements are current product-family context; confirm the exact cleared release and installed options.

SourceSource

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. AI-assisted measurements, views, and guidance do not replace image-quality assessment or clinician interpretation; supported probes, host devices, populations, and features differ by release.

exact submission · checked 2026-09-03

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-03

No exact-product price was found in the reviewed public material; vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: AI-assisted measurements, views, and guidance do not replace image-quality assessment or clinician interpretation; supported probes, host devices, populations, and features differ by release.

product family · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. Vendor statements are current product-family context; confirm the exact cleared release and installed options.

SourceSource

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
K251985 reports AI model testing on 49 subjects and 1,186 annotated images with overall accuracy 94.8%, sensitivity 0.91, specificity 0.98, and Dice 0.82. A Japanese UGFF study included 582 subjects and reported correlation 0.87 with MRI-PDFF; confirmatory US/EU testing included 15 subjects and reported correlation 0.90. These results apply to the named functions and tested populations, not every LOGIQ E10 examination.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Reported sensitivity
0.91 for the reported AI model evaluation on 49 subjects and 1,186 annotated images; endpoint-specific
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03

Endpoint-specific value reported in the exact FDA performance package; compare only with matching endpoint, threshold, population, and version.

Reported specificity
0.98 for the reported AI model evaluation on 49 subjects and 1,186 annotated images; endpoint-specific
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03

Endpoint-specific value reported in the exact FDA performance package; compare only with matching endpoint, threshold, population, and version.

Overall AI model accuracy

94.8 %

  • EndpointReported AI model evaluation
  • PopulationLOGIQ E10
  • Tested versionLOGIQ E10
Source

AI model sensitivity

0.91 proportion

  • EndpointReported AI model evaluation
  • PopulationLOGIQ E10
  • Tested versionLOGIQ E10
Source

AI model specificity

0.98 proportion

  • EndpointReported AI model evaluation
  • PopulationLOGIQ E10
  • Tested versionLOGIQ E10
Source

AI model Dice

0.82 coefficient

  • EndpointSegmentation overlap
  • PopulationLOGIQ E10
  • Tested versionLOGIQ E10
Source

UGFF correlation with MRI-PDFF

0.87 correlation

  • EndpointUltrasound-guided fat-fraction agreement
  • PopulationLOGIQ E10
  • Tested versionLOGIQ E10
Source

UGFF confirmatory correlation

0.9 correlation

  • EndpointUS/EU confirmatory agreement
  • PopulationLOGIQ E10
  • Tested versionLOGIQ E10
Source

K251985 FDA performance package for LOGIQ E10

  • DesignManufacturer AI model, software, and clinical validation for fetal biometry and ultrasound-guided fat-fraction functions
  • Population49-subject annotated-image AI evaluation; UGFF clinical study in Japan with 582 subjects; confirmatory US/EU study with 15 subjects
  • Scopeexact submission
  • Tested versionLOGIQ E10
  • IndependenceSponsor or vendor study

K251985

Manufacturer evidence submitted for FDA clearance or approval; local clinical, technical, and workflow acceptance remains necessary.

Source

5 unlinked candidate evidence records are retained for source review and excluded from this evidence display.

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-03

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging, procedural, or surgical service line and verify payer, site-of-service, and coding assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-03

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.

Source

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
The 2026-09-02 openFDA device-recall snapshot contained no record matched to K251985 by exact submission identifier. This does not exclude product-family, later, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

Exact-identifier review does not prove absence of all product-family safety signals.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-04Last searched
26Fields reviewed
13Source classes checked
20Screened PubMed leads
10Screened trial leads
0Unreviewed FDA recall leads

Twenty PubMed records and ten trial records were screened. Some concern ultrasound or LOGIQ-family use, but none establishes the exact K251985 system release and enabled functions as tested. No evidence was promoted, and all 30 candidates remain quarantined. The current discovery snapshot contains 20 PubMed and 10 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, fda decision material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA 510(k) decision material K251985: LOGIQ E10

    U.S. Food and Drug Administration - Published 2025-10-29 - Accessed 2026-09-04

    Scope: identity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  5. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. LOGIQ E10 general imaging ultrasound system

    GE HealthCare - Accessed 2026-09-03

    Scope: productFamily, workflowRole, integration, implementationCapabilities, currentCommercialContext

  8. Diagnostic value of high-frequency ultrasound assessment of the lacrimal glands for primary Sjögren's disease.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  9. Noninvasive Diagnosis of Chronic Exertional Compartment Syndrome With Shear Wave Elastography and Subharmonic-Aided Pressure Estimation.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  10. Technical assessment of resolution of handheld ultrasound devices and clinical implications.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  11. A Comparative Study of Commercially Available Ultrasound Contrast Agents for Sub-harmonic-Aided Pressure Estimation (SHAPE) in a Bladder Phantom.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  12. In Vitro and In Vivo Evaluation of Ultrasound-Triggered Release From Novel Spinal Device.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  13. Improved Sensitivity of Ultrasound-Based Subharmonic Aided Pressure Estimation Using Monodisperse Microbubbles.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  14. Wireless point-of-care ultrasound: First experiences with a new generation handheld device.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  15. Comparison of Magnetic Resonance-Based Elastography and Ultrasound Shear Wave Elastography in Patients With Suspicion of Nonalcoholic Fatty Liver Disease.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  16. Investigation Into the Subharmonic Response of Three Contrast Agents in Static and Dynamic Flow Environments Using a Commercially Available Diagnostic Ultrasound Scanner.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  17. Ultrasound Image Quality Assessment for Novel E4D Interventional Imaging Probe.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  18. Contrast-Enhanced B-Flow Ultrasound: A Novel Approach to Liver Trauma Imaging.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  19. Attenuation Coefficient Measurement Using a High-Frequency (2-9 MHz) Convex Transducer for Children Including Fatty Liver.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  20. Utilization of Shear Wave Elastography in the Evaluation of Pediatric Liver Transplant: A Prospective Case-Controlled Study.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  21. Development of a contrast-enhanced ultrasound-guided high-intensity focused ultrasound system for coagulation of liver parenchyma.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  22. Does Color Doppler Twinkling Change Between Ultrasound Platform Generations? - A Comparison Using Breast Biopsy Markers.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  23. Normal Values of Spleen Stiffness in Healthy Volunteers and Effect of Meal on Liver Stiffness and Spleen Stiffness.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  24. Liver shear wave elastography using a mechanical index exceeding regulatory limits is safe and effective.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  25. Ultrasound-Guided Attenuation Parameter (UGAP) for the quantification of liver steatosis using the Controlled Attenuation Parameter (CAP) as the reference method.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  26. Evaluation of image quality in five different handheld ultrasound devices and analysis of various impact factors.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  27. Contrast-enhanced ultrasound findings in GLUT1-negative congenital hemangiomas: a descriptive case series of superficial and hepatic lesions.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  28. Effects of Blood-flow Restricted Exercise Compared to Standard Rehabilitation in Patients With Knee Osteoarthritis

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  29. Evaluation of TaiHao Breast Ultrasound Diagnosis Software RN-CES Descartes

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  30. Sonography of the Nipple Areolar Complex

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  31. UNITE Study (UMN-GE) for COVID-19

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  32. Periprosthetic Joint Infection Bubble Study

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  33. SHAPE of Portal Hypertension in Children

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  34. Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension; Renewal

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  35. Mechanisms of Ultrasound Neuromodulation Effects in Diabetes

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  36. Ultrasound Treatment on Wound Healing Time

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  37. 3D Ultrasound Breast Imaging

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

Research history

  1. K251985 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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