FDA-cleared profile
EchoNous, Inc.
KOSMOS combines general-purpose ultrasound with synchronized three-lead single-channel ECG and digital auscultation for adult and pediatric cardiac, lung, abdominal, vascular, and procedure-guidance assessment.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
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.
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 K193518 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
DICOM and Wi-Fi support for patient-data archival, with offline acquisition and display; validate archive routing, time synchronization, ECG accessories, mobile handling, cleaning, and offline recovery.
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. The ECG is a timing reference rather than continuous diagnostic monitoring. K193518 did not include the later Auto EF or AI FAST functions, and the FDA summary reports no clinical study.
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: The ECG is a timing reference rather than continuous diagnostic monitoring. K193518 did not include the later Auto EF or AI FAST functions, and the FDA summary reports no clinical study.
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.
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.
Automated versus reference LVEF in KOSMOS.
Tested version: Later Kosmos product family with AutoEFAutomated versus reference LVEF in KOSMOS.
Tested version: Later Kosmos product family with AutoEFManufacturer nonclinical ultrasound, ECG, auscultation, software, safety, and usability verification · Adult and pediatric cardiac, thoracic, abdominal, vascular, and procedure-guidance use conditions
exact submission · Tested version: KOSMOS release cleared in K193518 · Sponsor or vendor studyK193518
Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.
Prospective consecutive-patient agreement study · 100 patients, including 38 with LVEF below 50%
product family · Tested version: Later Kosmos product family with AutoEF; not the K193518 feature set · n=100 · Independent studyPMID 36713988
Later product-family evidence only; K193518 did not clear AutoEF.
Economics and lifecycle
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.
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
Sources accessed through 2026-09-03.
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