FDA-cleared profile
GE Medical Systems Ultrasound and
Authorized purpose: Vivid E80, E90, and E95 are cardiovascular and general diagnostic ultrasound systems; K200743 adds AI-assisted cardiac measurements and Doppler-spectrum recognition, expanded ventricular and atrial function analysis, and qualified application-launch and DICOM-report functions.
Product overview
Authorized purpose: Vivid E80, E90, and E95 are cardiovascular and general diagnostic ultrasound systems; K200743 adds AI-assisted cardiac measurements and Doppler-spectrum recognition, expanded ventricular and atrial function analysis, and qualified application-launch and DICOM-report functions.
Overview status: Source-reviewed overview
Clinical role: Vivid E80, E90, and E95 are cardiovascular and general diagnostic ultrasound systems; K200743 adds AI-assisted cardiac measurements and Doppler-spectrum recognition, expanded ventricular and atrial function analysis, and qualified application-launch and DICOM-report functions.
Evidence from the reviewed source record: K200743 reports system verification and validation but no clinical study. The release-specific AI Auto Measure 2D workflow reduced required user interactions from 19 to four, described as a 79% reduction; outcome or diagnostic benefit was not established.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
The exact indications state use by, or under the direction of, a qualified and trained physician; they do not name cardiac sonographers or ultrasound professionals as additional user classes.
The exact device description and feature list state the transducer inputs and the raw-data/DICOM boundaries for AFI 3.0 and Auto EF 3.0 without the dossier's unsupported live-data and qualification wording.
The packet directly supports acquisition, processing, analysis, display, and read-only DICOM PDF access, but does not state that the system outputs DICOM reports.
The replacement retains only the exact qualified-application boundary and the exact clinical-study statement; later-release and clinical-interpretation claims are not in this packet.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
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.
Map the installed model, build, options, population, anatomy, inputs, and outputs to K200743 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
LAN or wireless DICOM workflow with storage, reporting, PDF read, and a launchpad restricted to qualified compatible applications; validate probe, archive, third-party DICOM, measurement, and report interoperability.
exact submission · checked 2026-09-03Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.
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. K200743 did not require clinical studies. AI Auto Measure and related tools automate defined measurements but do not replace acquisition quality review or clinical interpretation; later Vivid releases must not be attributed to this clearance.
exact submission · checked 2026-09-03Define stop-use, escalation, rollback, and revalidation triggers before production use.
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 2026-09-03Vendor productivity claims are scenario inputs, not guaranteed local savings.
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: K200743 did not require clinical studies. AI Auto Measure and related tools automate defined measurements but do not replace acquisition quality review or clinical interpretation; later Vivid releases must not be attributed to this clearance.
exact submission · checked 2026-09-03Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.
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.
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.
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.
79 %
K200743
Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
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.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
A zero-result exact-identifier search does not prove that no recall, correction, adverse-event report, or product-family safety signal exists.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
The refreshed discovery snapshot contains 20 PubMed and 10 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. 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, vendor product page, reimbursement policy, fda device recall, fda decision summary packet, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: purpose, modality, anatomy, intendedUsers, input, output, limitations, evidenceSummary, clinicalUse
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: coverage, codingContext
Scope: recallDiscovery, nativeSubmissionMatching
Scope: productFamily, workflowRole, integration, implementationCapabilities, currentCommercialContext
Regulatory record
510(k)
Research record
fda record reviewed
Editorial review
Source-reviewed editorial overlay
Alternatives
Ligence Uab
Ligence Heart is a fully automated software platform that processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, automatically producing a...
Ultrasight, Ltd.
PVAD IQ supports qualified-physician clinical decision support by identifying the aortic annulus and PVAD inlet, calculating their mean distance, and identifying clips acceptable...
Mycardium AI Limited
Transthoracic echocardiography view classification, cardiac structure segmentation, functional measurements and Doppler review and report support.
DiA Imaging Analysis Ltd.
Automated echocardiographic LV and RV function, wall-motion and strain, bladder-volume and image-quality measurements for clinician review.