Radiology AI Directory

FDA-cleared profile

LOGIQ E10

GE Medical Systems Ultrasound and Primary care Diagnostics

LOGIQ E10 provides broad diagnostic ultrasound imaging and fluid-flow analysis; this release adds AI-assisted renal measurements, anatomy-based preset and color suggestions, cardiac analysis, raw-data streaming, and Vscan Air CL support.

Cardiac imagingQuantification and segmentationUltrasound 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 provides broad diagnostic ultrasound imaging and fluid-flow analysis; this release adds AI-assisted renal measurements, anatomy-based preset and color suggestions, cardiac analysis, raw-data streaming, and Vscan Air CL support.
FDA source Exact FDA submission Checked 2026-09-03
Intended users
Qualified physicians, sonographers, and trained ultrasound professionals.
FDA source Exact FDA submission Checked 2026-09-03
Care setting and population
Hospitals and medical clinics performing general, vascular, cardiac, obstetric, pediatric, and procedural ultrasound.
FDA source Exact FDA submission Checked 2026-09-03
Workflow role
General diagnostic ultrasound acquisition, measurement, analysis, reporting, and AI-assisted exam setup or measurement.
Public source Exact FDA submission Checked 2026-09-03
Required input
Live ultrasound signals from supported probes, optional Vscan Air CL data, and supported patient or worklist information.
FDA source Exact FDA submission Checked 2026-09-03
Output and human action
Ultrasound images, Doppler data, measurements, cardiac analyses, suggested presets or anatomy views, reports, and streamed raw data where configured.
FDA source Exact FDA submission Checked 2026-09-03
Limitations
AI test sets were function-specific and relatively small for renal measurements. Wide-age-range anatomy-classification datasets did not collect exact age, and current LOGIQ family features should not be assumed present in the K231966 build.
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
K231966
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
2023-11-07
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
DICOM image and report workflows plus application launchpad and raw-data or network streaming described for this release; validate probe, console, PACS, reporting, worklist, archive, and third-party application compatibility.
Public source Exact FDA submission Checked 2026-09-03
Deployment and data flow
Installed mobile ultrasound console with supported probes, options, network interfaces, and local service infrastructure.
Public source Exact FDA submission Checked 2026-09-03
Security and privacy
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-03

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

Training and support
Only qualified physicians, sonographers, and trained ultrasound professionals. should operate or interpret the system. 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 and model 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 the limits that matter for this product: AI test sets were function-specific and relatively small for renal measurements. Wide-age-range anatomy-classification datasets did not collect exact age, and current LOGIQ family features should not be assumed present in the K231966 build.
Public source Exact FDA submission Checked 2026-09-03

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, and outputs to K231966 before acceptance.

exact submission · checked 2026-09-03

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

Source

Interoperability acceptance

DICOM image and report workflows plus application launchpad and raw-data or network streaming described for this release; validate probe, console, PACS, reporting, worklist, archive, and third-party application compatibility.

exact submission · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

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 test sets were function-specific and relatively small for renal measurements. Wide-age-range anatomy-classification datasets did not collect exact age, and current LOGIQ family features should not be assumed present in the K231966 build.

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

Vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software and model 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 the limits that matter for this product: AI test sets were function-specific and relatively small for renal measurements. Wide-age-range anatomy-classification datasets did not collect exact age, and current LOGIQ family features should not be assumed present in the K231966 build.

exact submission · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

SourceSource

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.

Evidence summary
K231966 includes prospective two-site testing of Auto Renal Measure Assistant and independent multinational image sets for Auto Abdominal Color Assistant and Auto Preset Assistant. Reported average renal-measurement accuracy exceeded 92%, while the anatomy-suggestion tools were tested against prespecified 80% success criteria.
Public source Exact FDA submission Checked 2026-09-03
Reported sensitivity
Not applicable
Not applicable Not applicable Checked 2026-09-03

Sensitivity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or quantitative-biomarker function. Use the task-specific endpoints and tested population reported below.

Reported specificity
Not applicable
Not applicable Not applicable Checked 2026-09-03

Specificity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or quantitative-biomarker function. Use the task-specific endpoints and tested population reported below.

Longitudinal renal measurement accuracy

96.45 %

Kidney length measurement accuracy in LOGIQ E10.

Tested version: LOGIQ E10 release cleared in K231966
Source

Longitudinal renal mean absolute error

0.35 cm

Kidney length absolute error in LOGIQ E10.

Tested version: LOGIQ E10 release cleared in K231966
Source

Transverse renal width accuracy

92.94 %

Kidney width measurement accuracy in LOGIQ E10.

Tested version: LOGIQ E10 release cleared in K231966
Source

Auto Abdominal Color test images

1100 images

Aorta, kidney, liver, gallbladder, and pancreas view suggestion in LOGIQ E10.

Tested version: LOGIQ E10 release cleared in K231966
Source

Auto Preset test images

2600 images

Anatomy and preset suggestion across supported applications in LOGIQ E10.

Tested version: LOGIQ E10 release cleared in K231966
Source

K231966 FDA performance package for LOGIQ E10

Manufacturer prospective renal-measurement validation and independent multicountry image-classification verification · Adults aged 26-81 for renal measurement plus diverse general-ultrasound image datasets

exact submission · Tested version: LOGIQ E10 release cleared in K231966 · n=30 · 2 sites · Sponsor or vendor study

K231966

Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.

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, enabled features, 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 device within the applicable imaging 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.

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 K231966 by exact submission identifier.
Public source Exact FDA submission Checked 2026-09-03

A zero-result exact-identifier search does not prove that no recall, correction, adverse-event report, or product-family safety signal exists.

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
24Fields reviewed
8Source classes checked
20Unreviewed PubMed leads
10Unreviewed trial leads
0Unreviewed FDA recall leads

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA materials, current product-family sources, selected clinical literature, reimbursement context, and exact-identifier recall candidates were reviewed. Pricing, contracted services, enabled options, final security architecture, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 20 PubMed and 10 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, vendor product page, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

Sources

Source ledger

Sources accessed through 2026-09-03.

Alternatives

Related tools to compare

FDA-cleared K201012

EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System

Philips Ultrasound, Inc.

The K201012 labeling covers Philips EPIQ, Affiniti, CX50, Sparq, and Lumify diagnostic ultrasound systems plus QLAB image viewing and quantification across labeled adult,...

Modality
Ultrasound
Anatomy
Multi-region
Decision
2020-05-01
Cardiac imagingQuantification and segmentationUltrasound workflow
FDA-cleared K251963

LOGIQ E10s

Ge Medical Systems Ultrasound and Primary Care Diagnostics

LOGIQ E10s is a general-purpose diagnostic ultrasound system supporting the labeled adult, pediatric, cardiac, vascular, abdominal, obstetric, small-organ, musculoskeletal,...

Modality
Ultrasound
Anatomy
Multi-region
Decision
2025-10-29
Cardiac imagingUltrasound workflow
FDA-cleared K251985

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,...

Modality
Ultrasound
Anatomy
Multi-region
Decision
2025-10-29
Breast imagingCardiac imagingUltrasound workflow