Radiology AI Directory

FDA-cleared profile

LOGIQ E10

Ge Medical Systems Ultrasound and Primary Care Diagnostics

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 shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.

Clinical fit

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.

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 %

Reported AI model evaluation in LOGIQ E10.

Tested version: LOGIQ E10
Source

AI model sensitivity

0.91 proportion

Reported AI model evaluation in LOGIQ E10.

Tested version: LOGIQ E10
Source

AI model specificity

0.98 proportion

Reported AI model evaluation in LOGIQ E10.

Tested version: LOGIQ E10
Source

AI model Dice

0.82 coefficient

Segmentation overlap in LOGIQ E10.

Tested version: LOGIQ E10
Source

UGFF correlation with MRI-PDFF

0.87 correlation

Ultrasound-guided fat-fraction agreement in LOGIQ E10.

Tested version: LOGIQ E10
Source

UGFF confirmatory correlation

0.9 correlation

US/EU confirmatory agreement in LOGIQ E10.

Tested version: LOGIQ E10
Source

K251985 FDA performance package for LOGIQ E10

Manufacturer AI model, software, and clinical validation for fetal biometry and ultrasound-guided fat-fraction functions · 49-subject annotated-image AI evaluation; UGFF clinical study in Japan with 582 subjects; confirmatory US/EU study with 15 subjects

exact submission · Tested version: LOGIQ E10 · Sponsor or vendor study

K251985

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

Source

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

Peer-reviewed literature candidate identified by exact-name search; full product and version applicability review pending · Multi-region or related Ultrasound workflow; exact product and version linkage not established

product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not established

40592723

Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.

Source

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

Peer-reviewed literature candidate identified by exact-name search; full product and version applicability review pending · Multi-region or related Ultrasound workflow; exact product and version linkage not established

product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not established

40798924

Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.

Source

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

Peer-reviewed literature candidate identified by exact-name search; full product and version applicability review pending · Multi-region or related Ultrasound workflow; exact product and version linkage not established

product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not established

38428463

Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.

Source

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

ClinicalTrials.gov candidate identified by exact-name search; full product and version applicability review pending · Multi-region or related Ultrasound workflow; exact product and version linkage not established

product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not established

NCT05437770

Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.

Source

Evaluation of TaiHao Breast Ultrasound Diagnosis Software RN-CES Descartes

ClinicalTrials.gov candidate identified by exact-name search; full product and version applicability review pending · Multi-region or related Ultrasound workflow; exact product and version linkage not established

product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not established

NCT05792475

Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.

Source

Economics and lifecycle

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
20Reviewed PubMed leads
10Reviewed 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

Source ledger

Sources accessed through 2026-09-04.

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