Radiology AI Directory

FDA-cleared profile

Kosmos

EchoNous, Inc.

Authorized purpose: Kosmos is tablet-based ultrasound for adult and pediatric cardiac, lung, abdominal, vascular, musculoskeletal, and procedure-guidance applications; Torso configurations can include ECG and digital auscultation.

Cardiac 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: Kosmos is tablet-based ultrasound for adult and pediatric cardiac, lung, abdominal, vascular, musculoskeletal, and procedure-guidance applications; Torso configurations can include ECG and digital auscultation.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Kosmos is tablet-based ultrasound for adult and pediatric cardiac, lung, abdominal, vascular, musculoskeletal, and procedure-guidance applications; Torso configurations can include ECG and digital auscultation.

Evidence takeaway

Evidence from the reviewed source record: K212100 reports system, software, probe, electrical, acoustic, and workflow validation. Current postmarket review identifies an iOS DICOM-export measurement issue limited to the affected software path.

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 is tablet-based ultrasound for adult and pediatric cardiac, lung, abdominal, vascular, musculoskeletal, and procedure-guidance applications; Torso configurations can include ECG and digital auscultation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.

Intended users
Qualified and trained healthcare professionals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact packet uses this general qualification and does not name the dossier's physician or sonographer subgroups.

Care setting and population
Hospitals, clinics, offices, and point-of-care environments within the device's 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
Ultrasound images, or synchronized ultrasound images, electrocardiogram (ECG) rhythms, and digital auscultation (DA) sounds and waveforms.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact packet states the acquired data types but does not establish imported ultrasound data from the prior value.

Output and human action
Ultrasound images, auscultation and ECG waveforms, and patient data/reports displayed on the tablet, with measurements and storage of the stated data.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact packet supports these displayed data and measurements but does not establish the prior calculations-and-overlays wording.

Limitations
The new AI-assisted EF Workflow and Trio tool are not yet cleared by the FDA.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

This is the exact packet's feature-clearance boundary; the prior image-quality and release-difference claims are not stated in the packet.

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
K212100
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Anatomy
Multi-region
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2021-08-06
  • 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
  • Exact FDA submission
  • Checked 2026-09-03
Deployment and data flow
Ultrasound hardware or software with supported probes, host devices, licensed options, and network configuration.
  • 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 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 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 these product-specific limits: AI-assisted measurements and views do not replace image-quality assessment or clinician interpretation; supported probes, host devices, populations, and features differ by release.
  • 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 K212100 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.

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-assisted measurements and views 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

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 these product-specific limits: AI-assisted measurements and views 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

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
K212100 reports system, software, probe, electrical, acoustic, and workflow validation. Current postmarket review identifies an iOS DICOM-export measurement issue limited to the affected software path.
  • FDA 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 endpoint for this acquisition, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

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

Specificity is not the primary endpoint for this acquisition, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

K212100 FDA performance package for Kosmos

  • DesignManufacturer ultrasound-system, software, and probe verification
  • PopulationBroad adult and pediatric point-of-care ultrasound applications
  • Scopeexact submission
  • Tested versionKosmos release cleared in K212100
  • IndependenceSponsor or vendor study

K212100

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

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 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
1 reviewed FDA recall record in the 2026-09-02 openFDA snapshot natively identify K212100. Confirm affected model, version, unit, correction, and current manufacturer instructions. FDA recall Z-2325-2024 affects Kosmos on iOS. A software defect could make measurements performed in third-party PACS or post-processing software inaccurate after DICOM export; FDA identifies version 2.1.4.53 as the corrective patch and lists the recall as open and classified.
  • FDA source
  • Exact product version
  • Checked 2026-09-04

Each published event was manually matched to the exact FDA submission and affected product or version; a recall does not establish an AI-algorithm defect or current site exposure unless the event states that scope.

recall: Z-2325-2024

Open, Classified

2024-07-10

Exact Kosmos on iOS match. The issue concerns exported images and downstream third-party measurements, not all measurements made in the product.

Source

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
27Fields reviewed
12Source classes checked
20Screened PubMed leads
10Screened trial leads
0Unreviewed FDA recall leads

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. 1 FDA recall candidate was manually reviewed: 1 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 1 postmarket candidate record; 1 has been reviewed (1 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, reimbursement policy, fda device recall, fda decision summary packet, 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 K212100: Kosmos

    U.S. Food and Drug Administration - Published 2021-08-06 - Accessed 2026-09-19

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

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. FDA recall Z-2325-2024: Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.

    U.S. Food and Drug Administration - Published 2024-07-10 - Accessed 2026-09-04

    Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction

  4. PubMed biomedical literature index

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

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

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

    Scope: evidenceDiscovery, studyStatus

  6. Medicare Coverage Database

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

    Scope: coverage, codingContext

  7. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

  8. Kosmos user guide

    EchoNous - Accessed 2026-09-03

    Scope: integration, deployment, monitoring, productFamilyContext

Research history

  1. K212100 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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