Radiology AI Directory

FDA-cleared profile

Kosmos

EchoNous, Inc.

Kosmos acquires, processes, displays, measures, and stores ultrasound with synchronized ECG and digital auscultation across cardiac, lung, abdominal, vascular, musculoskeletal, and interventional applications. Adult-only Auto EF and AI FAST are adjunct functions.

Cardiac imagingUltrasound workflowQuantification and segmentation
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

Kosmos acquires, processes, displays, measures, and stores ultrasound with synchronized ECG and digital auscultation across cardiac, lung, abdominal, vascular, musculoskeletal, and interventional applications. Adult-only Auto EF and AI FAST are adjunct functions.

Overview status: Field-derived fact summary This section is assembled from the sourced field records below; it is not a source-reviewed editorial overview.

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
Kosmos acquires, processes, displays, measures, and stores ultrasound with synchronized ECG and digital auscultation across cardiac, lung, abdominal, vascular, musculoskeletal, and interventional applications. Adult-only Auto EF and AI FAST are adjunct functions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Intended users
Qualified and trained healthcare professionals in clinical care and education.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Care setting and population
Healthcare facilities and educational settings; Auto EF is limited to adult use in healthcare facilities.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
Point-of-care ultrasound acquisition, measurement, auscultation, adult ejection-fraction assistance, and real-time anatomy labeling.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
Real-time ultrasound, synchronized ECG, and digital auscultation signals from compatible Kosmos hardware.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Output and human action
Ultrasound images, clips, measurements, auscultation information, adult LVEF estimates, and AI FAST anatomy labels.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Limitations
Auto EF is adult-only and adjunctive. AI FAST labels anatomy during cardiac, lung, and abdominal scanning but does not replace image interpretation. Confirm the exact hardware, software, probe, and feature configuration.
  • 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
K233826
  • 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
2024-08-29
  • 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
Image storage and DICOM or enterprise connectivity depend on exact configuration; test measurement preservation, identifiers, image scaling, clips, and reports.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Deployment and data flow
Portable point-of-care ultrasound platform with compatible probes and tablet or display hardware.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Security and privacy
Current vendor materials describe HIPAA and SOC 2 controls for the product family. Obtain the exact deployment architecture, report, scope, data flow, retention, support access, and incident-response evidence.
  • Vendor supplied
  • Product family
  • Checked 2026-09-03

Confirm the controls against the exact contracted architecture and release.

Training and support
Only qualified and trained healthcare professionals in clinical care and education. 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: Auto EF is adult-only and adjunctive. AI FAST labels anatomy during cardiac, lung, and abdominal scanning but does not replace image interpretation. Confirm the exact hardware, software, probe, and feature configuration.
  • 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 K233826 before acceptance.

exact submission · checked 2026-09-03

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

Source

Interoperability acceptance

Image storage and DICOM or enterprise connectivity depend on exact configuration; test measurement preservation, identifiers, image scaling, clips, and reports.

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. Auto EF is adult-only and adjunctive. AI FAST labels anatomy during cardiac, lung, and abdominal scanning but does not replace image interpretation. Confirm the exact hardware, software, probe, and feature configuration.

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: Auto EF is adult-only and adjunctive. AI FAST labels anatomy during cardiac, lung, and abdominal scanning but does not replace image interpretation. Confirm the exact hardware, software, probe, and feature configuration.

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. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
K233826 defines the exact broad imaging, adult Auto EF, and AI FAST indications. A 100-patient peer-reviewed AutoEF evaluation reported strong agreement with reference echocardiography but is product-family evidence unless the tested build is mapped to K233826.
  • 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 dose-delivery 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 dose-delivery function. Use the task-specific endpoints and tested population reported below.

AutoEF intraclass correlation

0.85 ICC

  • EndpointAutomated versus reference LVEF
  • PopulationKosmos
  • Tested versionKosmos product family
Source

AutoEF correlation

0.87 Pearson r

  • EndpointAutomated versus reference LVEF
  • PopulationKosmos
  • Tested versionKosmos product family
Source

K233826 FDA performance package for Kosmos

  • DesignManufacturer system, probe, acoustic-output, image-quality, Auto EF, AI FAST, ECG, auscultation, software, and usability verification
  • PopulationRepresentative cardiac, lung, abdominal, vascular, musculoskeletal, and interventional point-of-care studies
  • Scopeexact submission
  • Tested versionKosmos release cleared in K233826
  • IndependenceSponsor or vendor study

K233826

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

Source

AI-assisted ejection fraction assessment with handheld ultrasound

  • DesignProspective consecutive-patient agreement study
  • Population100 patients; 61% male and 38 with LVEF below 50%
  • Scopeproduct family
  • Tested versionKosmos product family; exact K233826 build not established
  • Samplen=100
  • IndependenceIndependent study

PMID 36713988

Product-family evidence; agreement does not establish interchangeability for every patient or release.

Source

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, 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 K233826 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
9Source classes checked
20Awaiting review PubMed leads
10Awaiting review 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, peer reviewed publication, reimbursement policy, fda device recall, 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. K233826 FDA decision source

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

    Scope: regulatoryIdentity, purpose, modality, anatomy

  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. Kosmos point-of-care ultrasound product family

    EchoNous - Accessed 2026-09-03

    Scope: productFamily, workflowRole, security, training, implementationCapabilities, currentCommercialContext

  8. Artificial-intelligence-assisted ejection fraction assessment with a handheld ultrasound device

    European Heart Journal - Digital Health - Accessed 2026-09-03

    Scope: limitations, evidenceSummary, evidenceStudy, evidenceMetrics, monitoring

Research history

  1. K233826 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

Alternatives

Related tools to compare

FDA-cleared K231966

LOGIQ E10

GE Medical Systems Ultrasound and Primary care Diagnostics

LOGIQ E10 is a general-purpose diagnostic ultrasound system for broad adult and pediatric applications; K231966 adds AI-assisted renal measurements, anatomy-based preset and color...

Modality
Ultrasound
Anatomy
Multi-region
Decision
2023-11-07
Cardiac imagingQuantification and segmentationUltrasound workflow
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